Drugs@FDA: FDA Approved Drug Products

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

September 18, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetaminophen and Codeine Phosphate
ANDA #040119
Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-13 Hi Tech Pharma REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #040419
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-24 Specgx Llc REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #040779
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-19 Amneal Pharms Ny REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #081249
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-11 Fosun Pharma REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #081250
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-11 Fosun Pharma REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #085861
Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-77 Actavis Mid Atlantic REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #085868
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-63 Sun Pharm Inds Ltd REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #087006
Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-33 Wockhardt Bio Ag REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #087083
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-50 Sun Pharm Inds Ltd REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #087508
Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-43 Pharm Assoc REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #088627
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-60 Teva REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #088628
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-69 Teva REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #088629
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-68 Teva REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089450
Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-24 Mikart REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089805
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-31 Vintage REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089828
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-29 Vintage Pharms REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089990
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-26 Vintage REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089997
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-21 Watson Labs REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089998
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-21 Watson Labs REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089999
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-20 Watson Labs REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #091238
Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-15 Lannett Co Inc REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #202800
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-9 Aurolife Pharma Llc REMS Approved
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate
ANDA #204209
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate Tablet; Oral SUPPL-7 Larken Labs Inc REMS Approved
Anexsia 5/325
ANDA #040409
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-27 Specgx Llc REMS Approved
Anexsia 7.5/325
ANDA #040405
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-27 Specgx Llc REMS Approved
Apadaz
NDA #208653
Acetaminophen; Benzhydrocodone Hydrochloride Tablet; Oral SUPPL-2 Kempharm Labeling Approved
Apadaz
NDA #208653
Acetaminophen; Benzhydrocodone Hydrochloride Tablet; Oral SUPPL-3 Kempharm REMS Approved
Arymo Er
NDA #208603
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-4 Egalet Labeling Approved
Arymo Er
NDA #208603
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-3 Egalet REMS Approved
Belbuca
NDA #207932
Buprenorphine Hydrochloride Film; Buccal SUPPL-9 Bdsi Labeling Approved
Belbuca
NDA #207932
Buprenorphine Hydrochloride Film; Buccal SUPPL-9 Bdsi Labeling Approved
Belbuca
NDA #207932
Buprenorphine Hydrochloride Film; Buccal SUPPL-8 Bdsi REMS Approved
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
ANDA #075618
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-27 Hikma Intl Pharms REMS Approved
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
ANDA #075929
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-24 Vintage Pharms REMS Approved
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
ANDA #076560
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-8 Nexgen Pharma Inc REMS Approved
Butalbital, Aspirin, Caffeine and Codeine Phosphate
ANDA #203335
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-5 Mayne Pharma Inc REMS Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #074359
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-14 Watson Labs REMS Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #074951
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-4 Stevens J REMS Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #075231
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-8 Nexgen Pharma Inc REMS Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #075351
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-5 Vintage Pharms Llc REMS Approved
Butorphanol Tartrate
ANDA #075499
Butorphanol Tartrate Spray, Metered; Nasal SUPPL-24 Apotex Inc REMS Approved
Butorphanol Tartrate
ANDA #075759
Butorphanol Tartrate Spray, Metered; Nasal SUPPL-28 Mylan REMS Approved
Butorphanol Tartrate
ANDA #075824
Butorphanol Tartrate Spray, Metered; Nasal SUPPL-11 West-Ward Pharms Int REMS Approved
Butrans
NDA #021306
Buprenorphine Film, Extended Release; Transdermal SUPPL-34 Purdue Pharma Lp Labeling Approved
Butrans
NDA #021306
Buprenorphine Film, Extended Release; Transdermal SUPPL-34 Purdue Pharma Lp Labeling Approved
Butrans
NDA #021306
Buprenorphine Film, Extended Release; Transdermal SUPPL-32 Purdue Pharma Lp REMS Approved
Carisoprodol, Aspirin and Codeine Phosphate
ANDA #040118
Aspirin; Carisoprodol; Codeine Phosphate Tablet; Oral SUPPL-17 Sandoz REMS Approved
Carisoprodol, Aspirin and Codeine Phosphate
ANDA #040860
Aspirin; Carisoprodol; Codeine Phosphate Tablet; Oral SUPPL-3 Ingenus Pharms Nj REMS Approved
Codeine Sulfate
NDA #022402
Codeine Sulfate Tablet; Oral SUPPL-11 West-Ward Pharms Int Labeling Approved
Codeine Sulfate
NDA #022402
Codeine Sulfate Tablet; Oral SUPPL-10 West-Ward Pharms Int REMS Approved
Codeine Sulfate
NDA #202245
Codeine Sulfate Solution; Oral SUPPL-7 West-Ward Pharms Int Labeling Approved
Codeine Sulfate
NDA #202245
Codeine Sulfate Solution; Oral SUPPL-6 West-Ward Pharms Int REMS Approved
Codeine Sulfate
ANDA #203046
Codeine Sulfate Tablet; Oral SUPPL-7 Lannett Co Inc REMS Approved
Conzip
NDA #022370
Tramadol Hydrochloride Capsule, Extended Release; Oral SUPPL-17 Cipher Pharms Inc Labeling Approved
Conzip
NDA #022370
Tramadol Hydrochloride Capsule, Extended Release; Oral SUPPL-16 Cipher Pharms Inc REMS Approved
Demerol
NDA #005010
Meperidine Hydrochloride Injectable; Injection SUPPL-57 Us Pharm Holdings Labeling Approved
Demerol
NDA #005010
Meperidine Hydrochloride Injectable; Injection SUPPL-56 Us Pharm Holdings REMS Approved
Demerol
NDA #005010
Meperidine Hydrochloride Syrup; Oral SUPPL-57 Us Pharm Holdings Labeling Approved
Demerol
NDA #005010
Meperidine Hydrochloride Syrup; Oral SUPPL-56 Us Pharm Holdings REMS Approved
Demerol
NDA #005010
Meperidine Hydrochloride Tablet; Oral SUPPL-57 Us Pharm Holdings Labeling Approved
Demerol
NDA #005010
Meperidine Hydrochloride Tablet; Oral SUPPL-56 Us Pharm Holdings REMS Approved
Dilaudid
NDA #019891
Hydromorphone Hydrochloride Solution; Oral SUPPL-27 Rhodes Pharms Labeling Approved
Dilaudid
NDA #019891
Hydromorphone Hydrochloride Solution; Oral SUPPL-26 Rhodes Pharms REMS Approved
Dilaudid
NDA #019892
Hydromorphone Hydrochloride Tablet; Oral SUPPL-34 Rhodes Pharms Labeling Approved
Dilaudid
NDA #019892
Hydromorphone Hydrochloride Tablet; Oral SUPPL-33 Rhodes Pharms REMS Approved
Dolophine Hydrochloride
NDA #006134
Methadone Hydrochloride Syrup; Oral SUPPL-48 West-Ward Pharms Int Labeling Approved
Dolophine Hydrochloride
NDA #006134
Methadone Hydrochloride Syrup; Oral SUPPL-46 West-Ward Pharms Int REMS Approved
Dolophine Hydrochloride
NDA #006134
Methadone Hydrochloride Tablet; Oral SUPPL-48 West-Ward Pharms Int Labeling Approved
Dolophine Hydrochloride
NDA #006134
Methadone Hydrochloride Tablet; Oral SUPPL-46 West-Ward Pharms Int REMS Approved
Duragesic-100
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-76 Janssen Pharms Labeling Approved
Duragesic-100
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-75 Janssen Pharms REMS Approved
Duragesic-12
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-76 Janssen Pharms Labeling Approved
Duragesic-12
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-75 Janssen Pharms REMS Approved
Duragesic-25
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-76 Janssen Pharms Labeling Approved
Duragesic-25
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-75 Janssen Pharms REMS Approved
Duragesic-37
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-76 Janssen Pharms Labeling Approved
Duragesic-37
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-75 Janssen Pharms REMS Approved
Duragesic-50
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-76 Janssen Pharms Labeling Approved
Duragesic-50
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-75 Janssen Pharms REMS Approved
Duragesic-75
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-76 Janssen Pharms Labeling Approved
Duragesic-75
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-75 Janssen Pharms REMS Approved
Embeda
NDA #022321
Morphine Sulfate; Naltrexone Hydrochloride Capsule, Extended Release; Oral SUPPL-29 Alpharma Pharms Labeling Approved
Embeda
NDA #022321
Morphine Sulfate; Naltrexone Hydrochloride Capsule, Extended Release; Oral SUPPL-28 Alpharma Pharms REMS Approved
Exalgo
NDA #021217
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-24 Specgx Llc Labeling Approved
Exalgo
NDA #021217
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-23 Specgx Llc REMS Approved
Fentanyl-100
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-100
ANDA #076709
Fentanyl Film, Extended Release; Transdermal SUPPL-31 Actavis Labs Ut Inc REMS Approved
Fentanyl-100
ANDA #077062
Fentanyl Film, Extended Release; Transdermal SUPPL-38 Mayne Pharma REMS Approved
Fentanyl-100
ANDA #077154
Fentanyl Film, Extended Release; Transdermal SUPPL-20 Specgx Llc REMS Approved
Fentanyl-100
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-100
ANDA #202097
Fentanyl Film, Extended Release; Transdermal SUPPL-4 3m Drug Delivery REMS Approved
Fentanyl-12
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-12
ANDA #077154
Fentanyl Film, Extended Release; Transdermal SUPPL-20 Specgx Llc REMS Approved
Fentanyl-12
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-12
ANDA #202097
Fentanyl Film, Extended Release; Transdermal SUPPL-4 3m Drug Delivery REMS Approved
Fentanyl-25
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-25
ANDA #076709
Fentanyl Film, Extended Release; Transdermal SUPPL-31 Actavis Labs Ut Inc REMS Approved
Fentanyl-25
ANDA #077062
Fentanyl Film, Extended Release; Transdermal SUPPL-38 Mayne Pharma REMS Approved
Fentanyl-25
ANDA #077154
Fentanyl Film, Extended Release; Transdermal SUPPL-20 Specgx Llc REMS Approved
Fentanyl-25
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-25
ANDA #202097
Fentanyl Film, Extended Release; Transdermal SUPPL-4 3m Drug Delivery REMS Approved
Fentanyl-37
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-37
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-50
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-50
ANDA #076709
Fentanyl Film, Extended Release; Transdermal SUPPL-31 Actavis Labs Ut Inc REMS Approved
Fentanyl-50
ANDA #077062
Fentanyl Film, Extended Release; Transdermal SUPPL-38 Mayne Pharma REMS Approved
Fentanyl-50
ANDA #077154
Fentanyl Film, Extended Release; Transdermal SUPPL-20 Specgx Llc REMS Approved
Fentanyl-50
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-50
ANDA #202097
Fentanyl Film, Extended Release; Transdermal SUPPL-4 3m Drug Delivery REMS Approved
Fentanyl-62
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-62
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-75
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-75
ANDA #076709
Fentanyl Film, Extended Release; Transdermal SUPPL-31 Actavis Labs Ut Inc REMS Approved
Fentanyl-75
ANDA #077062
Fentanyl Film, Extended Release; Transdermal SUPPL-38 Mayne Pharma REMS Approved
Fentanyl-75
ANDA #077154
Fentanyl Film, Extended Release; Transdermal SUPPL-20 Specgx Llc REMS Approved
Fentanyl-75
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-75
ANDA #202097
Fentanyl Film, Extended Release; Transdermal SUPPL-4 3m Drug Delivery REMS Approved
Fentanyl-87
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-87
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fioricet W/ Codeine
NDA #020232
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-43 Actavis Labs Ut Inc Labeling Approved
Fioricet W/ Codeine
NDA #020232
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-42 Actavis Labs Ut Inc REMS Approved
Fiorinal W/Codeine
NDA #019429
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-42 Allergan Sales Llc Labeling Approved
Fiorinal W/Codeine
NDA #019429
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-41 Allergan Sales Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040148
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-71 Apil REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040248
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Watson Labs REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040355
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-35 Vintage Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040400
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-27 Specgx Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040432
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-11 Mikart REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040482
Acetaminophen; Hydrocodone Bitartrate Solution; Oral SUPPL-19 Mikart REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040655
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-25 Vintage Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040656
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-25 Vintage Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040658
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-12 Mikart REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040736
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-18 Amneal Pharms Ny REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040746
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-20 Amneal Pharms Ny REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040826
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-9 Sun Pharm Inds Ltd REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040834
Acetaminophen; Hydrocodone Bitartrate Solution; Oral SUPPL-12 Pharm Assoc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040838
Acetaminophen; Hydrocodone Bitartrate Solution; Oral SUPPL-11 Pharm Assoc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040846
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-11 Mikart REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040881
Acetaminophen; Hydrocodone Bitartrate Solution; Oral SUPPL-10 Mikart REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040894
Acetaminophen; Hydrocodone Bitartrate Solution; Oral SUPPL-10 Genus Lifesciences REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #090118
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-27 Sun Pharm Inds Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #090415
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-16 Vintage Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #200343
Acetaminophen; Hydrocodone Bitartrate Solution; Oral SUPPL-4 Vistapharm REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #201013
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-11 Aurolife Pharma Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #202214
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-8 Tris Pharma Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #202935
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-3 Par Pharm REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #202991
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-4 Rhodes Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #203863
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Epic Pharma Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #205001
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-2 Par Pharm REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #206142
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-2 Novel Labs Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #206245
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Novel Labs Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #206470
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Actavis Labs Fl Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #206484
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Upsher-Smith Labs REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #206718
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Specgx Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #206869
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Amneal Pharms Ny REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207137
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-2 Amneal Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207171
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-2 Lannett Co Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207172
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-2 Lannett Co Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207709
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Aurolife Pharma Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207808
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Rhodes Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #209036
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Abhai Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #209037
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Abhai Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #210211
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Wes Pharma Inc REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #076023
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-19 Teva REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #076604
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-20 Actavis Labs Fl Inc REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #076642
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-25 Amneal Pharms Ny REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077454
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-3 Actavis Labs Fl Inc REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077723
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-21 Vintage Pharms REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077727
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-17 Vintage Pharms REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #091633
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-7 Sun Pharm Inds Inc REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #204575
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-2 Aurolife Pharma Llc REMS Approved
Hydromorphone Hydrochloride
ANDA #074597
Hydromorphone Hydrochloride Tablet; Oral SUPPL-15 West-Ward Pharms Int REMS Approved
Hydromorphone Hydrochloride
ANDA #074653
Hydromorphone Hydrochloride Solution; Oral SUPPL-9 West-Ward Pharms Int REMS Approved
Hydromorphone Hydrochloride
ANDA #076723
Hydromorphone Hydrochloride Tablet; Oral SUPPL-8 Elite Labs REMS Approved
Hydromorphone Hydrochloride
ANDA #076855
Hydromorphone Hydrochloride Tablet; Oral SUPPL-13 Specgx Llc REMS Approved
Hydromorphone Hydrochloride
ANDA #077471
Hydromorphone Hydrochloride Tablet; Oral SUPPL-12 Lannett Co Inc REMS Approved
Hydromorphone Hydrochloride
ANDA #202144
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-15 Actavis Labs Fl Inc REMS Approved
Hydromorphone Hydrochloride
ANDA #204278
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-12 Paddock Llc REMS Approved
Hydromorphone Hydrochloride
ANDA #205629
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-6 Osmotica REMS Approved
Hydromorphone Hydrochloride
ANDA #205814
Hydromorphone Hydrochloride Tablet; Oral SUPPL-2 Aurolife Pharma Llc REMS Approved
Hydromorphone Hydrochloride
ANDA #210176
Hydromorphone Hydrochloride Solution; Oral SUPPL-2 Ascent Pharms Inc REMS Approved
Hydromorphone Hydrochloride
ANDA #210506
Hydromorphone Hydrochloride Tablet; Oral SUPPL-2 Ascent Pharms Inc REMS Approved
Hysingla
NDA #206627
Hydrocodone Bitartrate Tablet, Extended Release; Oral SUPPL-8 Purdue Pharma Lp Labeling Approved
Hysingla
NDA #206627
Hydrocodone Bitartrate Tablet, Extended Release; Oral SUPPL-8 Purdue Pharma Lp Labeling Approved
Hysingla
NDA #206627
Hydrocodone Bitartrate Tablet, Extended Release; Oral SUPPL-7 Purdue Pharma Lp REMS Approved
Kadian
NDA #020616
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-62 Allergan Sales Llc Labeling Approved
Kadian
NDA #020616
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-61 Allergan Sales Llc REMS Approved
Levorphanol Tartrate
ANDA #074278
Levorphanol Tartrate Tablet; Oral SUPPL-12 Sentynl Theraps Inc REMS Approved
Meperidine Hydrochloride
ANDA #040110
Meperidine Hydrochloride Tablet; Oral SUPPL-6 West-Ward Pharms Int REMS Approved
Meperidine Hydrochloride
ANDA #040186
Meperidine Hydrochloride Tablet; Oral SUPPL-9 Watson Labs REMS Approved
Meperidine Hydrochloride
ANDA #040191
Meperidine Hydrochloride Tablet; Oral SUPPL-14 Vintage Pharms REMS Approved
Meperidine Hydrochloride
ANDA #040331
Meperidine Hydrochloride Tablet; Oral SUPPL-16 Epic Pharma REMS Approved
Meperidine Hydrochloride
ANDA #040352
Meperidine Hydrochloride Tablet; Oral SUPPL-5 Specgx Llc REMS Approved
Meperidine Hydrochloride
ANDA #040446
Meperidine Hydrochloride Tablet; Oral SUPPL-11 Sun Pharm Inds Inc REMS Approved
Meperidine Hydrochloride
ANDA #040893
Meperidine Hydrochloride Tablet; Oral SUPPL-4 Mikart REMS Approved
Meperidine Hydrochloride
ANDA #080448
Meperidine Hydrochloride Tablet; Oral SUPPL-21 Sun Pharm Industries REMS Approved
Meperidine Hydrochloride
ANDA #088639
Meperidine Hydrochloride Tablet; Oral SUPPL-40 Barr REMS Approved
Meperidine Hydrochloride
ANDA #088640
Meperidine Hydrochloride Tablet; Oral SUPPL-42 Barr REMS Approved
Meperidine Hydrochloride
ANDA #088744
Meperidine Hydrochloride Syrup; Oral SUPPL-27 West-Ward Pharms Int REMS Approved
Methadone Hydrochloride
ANDA #040241
Methadone Hydrochloride Tablet; Oral SUPPL-19 Sandoz REMS Approved
Methadone Hydrochloride
ANDA #040517
Methadone Hydrochloride Tablet; Oral SUPPL-25 Specgx Llc REMS Approved
Methadone Hydrochloride
ANDA #075082
Methadone Hydrochloride Tablet, For Suspension; Oral SUPPL-8 Sandoz REMS Approved
Methadone Hydrochloride
ANDA #077142
Methadone Hydrochloride Tablet, For Suspension; Oral SUPPL-17 Specgx Llc REMS Approved
Methadone Hydrochloride
ANDA #087393
Methadone Hydrochloride Solution; Oral SUPPL-46 West-Ward Pharms Int REMS Approved
Methadone Hydrochloride
ANDA #087997
Methadone Hydrochloride Solution; Oral SUPPL-38 West-Ward Pharms Int REMS Approved
Methadone Hydrochloride
ANDA #090065
Methadone Hydrochloride Tablet; Oral SUPPL-9 Epic Pharma Llc REMS Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-20 Thepharmanetwork Llc REMS Approved
Methadone Hydrochloride
ANDA #090707
Methadone Hydrochloride Solution; Oral SUPPL-17 Vistapharm REMS Approved
Methadone Hydrochloride
ANDA #203502
Methadone Hydrochloride Tablet; Oral SUPPL-5 Aurolife Pharma Llc REMS Approved
Methadone Hydrochloride
ANDA #208305
Methadone Hydrochloride Tablet; Oral SUPPL-2 Sun Pharm Industries REMS Approved
Methadone Hydrochloride
ANDA #210484
Methadone Hydrochloride Tablet; Oral SUPPL-1 Elite Labs Inc REMS Approved
Methadone Hydrochloride Intensol
ANDA #089897
Methadone Hydrochloride Concentrate; Oral SUPPL-39 West-Ward Pharms Int REMS Approved
Methadose
ANDA #040050
Methadone Hydrochloride Tablet; Oral SUPPL-27 Specgx Llc REMS Approved
Methadose
ANDA #074184
Methadone Hydrochloride Tablet, For Suspension; Oral SUPPL-22 Specgx Llc REMS Approved
Morphabond Er
NDA #206544
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-10 Daiichi Sankyo Inc Labeling Approved
Morphabond Er
NDA #206544
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-8 Daiichi Sankyo Inc REMS Approved
Morphine Sulfate
NDA #022195
Morphine Sulfate Solution; Oral SUPPL-16 West-Ward Pharms Int Labeling Approved
Morphine Sulfate
NDA #022195
Morphine Sulfate Solution; Oral SUPPL-14 West-Ward Pharms Int REMS Approved
Morphine Sulfate
NDA #022207
Morphine Sulfate Tablet; Oral SUPPL-8 West-Ward Pharms Int Labeling Approved
Morphine Sulfate
NDA #022207
Morphine Sulfate Tablet; Oral SUPPL-7 West-Ward Pharms Int REMS Approved
Morphine Sulfate
ANDA #074769
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-29 Rhodes Pharms REMS Approved
Morphine Sulfate
ANDA #074862
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-28 Rhodes Pharms REMS Approved
Morphine Sulfate
ANDA #075295
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-51 Vintage Pharms Llc REMS Approved
Morphine Sulfate
ANDA #076412
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-28 Specgx Llc REMS Approved
Morphine Sulfate
ANDA #076438
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-25 Specgx Llc REMS Approved
Morphine Sulfate
ANDA #076720
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-23 Nesher Pharms REMS Approved
Morphine Sulfate
ANDA #076733
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-22 Nesher Pharms REMS Approved
Morphine Sulfate
ANDA #077855
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-20 Nesher Pharms REMS Approved
Morphine Sulfate
ANDA #078761
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-13 Sun Pharm Inds Ltd REMS Approved
Morphine Sulfate
ANDA #079040
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-18 Actavis Elizabeth REMS Approved
Morphine Sulfate
ANDA #091357
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-4 Epic Pharma Llc REMS Approved
Morphine Sulfate
ANDA #200411
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-10 Impax Labs Inc REMS Approved
Morphine Sulfate
ANDA #200812
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-13 Par Pharm Inc REMS Approved
Morphine Sulfate
ANDA #200824
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-17 Mylan Pharms Inc REMS Approved
Morphine Sulfate
ANDA #201011
Morphine Sulfate Solution; Oral SUPPL-1 Nostrum Labs Inc REMS Approved
Morphine Sulfate
NDA #201517
Morphine Sulfate Solution; Oral SUPPL-13 Lannett Co Inc Labeling Approved
Morphine Sulfate
NDA #201517
Morphine Sulfate Solution; Oral SUPPL-12 Lannett Co Inc REMS Approved
Morphine Sulfate
ANDA #201574
Morphine Sulfate Solution; Oral SUPPL-3 Paddock Llc REMS Approved
Morphine Sulfate
ANDA #201947
Morphine Sulfate Solution; Oral SUPPL-4 Vistapharm REMS Approved
Morphine Sulfate
ANDA #202104
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-11 Upsher-Smith Labs REMS Approved
Morphine Sulfate
ANDA #202309
Morphine Sulfate Solution; Oral SUPPL-2 Lannett Co Inc REMS Approved
Morphine Sulfate
ANDA #202310
Morphine Sulfate Solution; Oral SUPPL-2 Lannett Co Inc REMS Approved
Morphine Sulfate
ANDA #202348
Morphine Sulfate Solution; Oral SUPPL-6 Specgx Llc REMS Approved
Morphine Sulfate
ANDA #202718
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-7 Teva Pharms Usa REMS Approved
Morphine Sulfate
ANDA #203518
Morphine Sulfate Solution; Oral SUPPL-4 Tris Pharma Inc REMS Approved
Morphine Sulfate
ANDA #203519
Morphine Sulfate Solution; Oral SUPPL-2 Tris Pharma Inc REMS Approved
Morphine Sulfate
ANDA #203602
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-7 Novel Labs Inc REMS Approved
Morphine Sulfate
ANDA #203849
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-15 Actavis Elizabeth REMS Approved
Morphine Sulfate
ANDA #205386
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-5 Mayne Pharma Inc REMS Approved
Morphine Sulfate
ANDA #205509
Morphine Sulfate Solution; Oral SUPPL-1 Ani Pharms Inc REMS Approved
Morphine Sulfate
ANDA #205634
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-5 Sun Pharm Industries REMS Approved
Morphine Sulfate
ANDA #206308
Morphine Sulfate Solution; Oral SUPPL-1 Rhodes Pharms REMS Approved
Morphine Sulfate
ANDA #206420
Morphine Sulfate Solution; Oral SUPPL-1 Rhodes Pharms REMS Approved
Morphine Sulfate
ANDA #206573
Morphine Sulfate Solution; Oral SUPPL-1 Pharm Assoc REMS Approved
Morphine Sulfate
ANDA #208809
Morphine Sulfate Solution; Oral SUPPL-1 Hi-Tech Pharmacal REMS Approved
Ms Contin
NDA #019516
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-54 Purdue Pharma Lp Labeling Approved
Ms Contin
NDA #019516
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-54 Purdue Pharma Lp Labeling Approved
Ms Contin
NDA #019516
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-53 Purdue Pharma Lp REMS Approved
Naloxone Hydrochloride and Pentazocine Hydrochloride
ANDA #074736
Naloxone Hydrochloride; Pentazocine Hydrochloride Tablet; Oral SUPPL-33 Watson Labs REMS Approved
Naloxone Hydrochloride and Pentazocine Hydrochloride
ANDA #075523
Naloxone Hydrochloride; Pentazocine Hydrochloride Tablet; Oral SUPPL-3 Sun Pharm Inds Ltd REMS Approved
Naloxone Hydrochloride and Pentazocine Hydrochloride
ANDA #075735
Naloxone Hydrochloride; Pentazocine Hydrochloride Tablet; Oral SUPPL-13 Gavis Pharms REMS Approved
Norco
ANDA #040099
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-21 Apil REMS Approved
Norco
ANDA #040148
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-71 Apil REMS Approved
Nucynta
NDA #022304
Tapentadol Hydrochloride Tablet; Oral SUPPL-21 Depomed Inc Labeling Approved
Nucynta
NDA #022304
Tapentadol Hydrochloride Tablet; Oral SUPPL-19 Depomed Inc REMS Approved
Nucynta
NDA #203794
Tapentadol Hydrochloride Solution; Oral SUPPL-6 Depomed Inc Labeling Approved
Nucynta
NDA #203794
Tapentadol Hydrochloride Solution; Oral SUPPL-5 Depomed Inc REMS Approved
Nucynta Er
NDA #200533
Tapentadol Hydrochloride Tablet, Extended Release; Oral SUPPL-19 Depomed Inc Labeling Approved
Nucynta Er
NDA #200533
Tapentadol Hydrochloride Tablet, Extended Release; Oral SUPPL-18 Depomed Inc REMS Approved
Opana
NDA #021611
Oxymorphone Hydrochloride Tablet; Oral SUPPL-15 Endo Pharms Labeling Approved
Opana
NDA #021611
Oxymorphone Hydrochloride Tablet; Oral SUPPL-13 Endo Pharms REMS Approved
Opana Er
NDA #021610
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-26 Endo Pharms Labeling Approved
Opana Er
NDA #021610
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-25 Endo Pharms REMS Approved
Opana Er
NDA #201655
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-25 Endo Pharms Labeling Approved
Opana Er
NDA #201655
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-24 Endo Pharms REMS Approved
Oxaydo
NDA #202080
Oxycodone Hydrochloride Tablet; Oral SUPPL-10 Egalet Us Inc Labeling Approved
Oxaydo
NDA #202080
Oxycodone Hydrochloride Tablet; Oral SUPPL-9 Egalet Us Inc REMS Approved
Oxycet
ANDA #087463
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-42 Specgx Llc REMS Approved
Oxycodone and Acetaminophen
ANDA #040105
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-31 Vintage Pharms REMS Approved
Oxycodone and Acetaminophen
ANDA #040171
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-33 Watson Labs REMS Approved
Oxycodone and Acetaminophen
ANDA #040203
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-9 Actavis Elizabeth REMS Approved
Oxycodone and Acetaminophen
ANDA #040535
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-33 Watson Labs REMS Approved
Oxycodone and Acetaminophen
ANDA #040545
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-15 Specgx Llc REMS Approved
Oxycodone and Acetaminophen
ANDA #040608
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-13 Mikart REMS Approved
Oxycodone and Acetaminophen
ANDA #040680
Acetaminophen; Oxycodone Hydrochloride Solution; Oral SUPPL-11 Specgx Llc REMS Approved
Oxycodone and Acetaminophen
ANDA #040777
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-14 Amneal Pharms REMS Approved
Oxycodone and Acetaminophen
ANDA #040778
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-16 Amneal Pharms Ny REMS Approved
Oxycodone and Acetaminophen
ANDA #040800
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-5 Actavis Elizabeth REMS Approved
Oxycodone and Acetaminophen
ANDA #090177
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-12 Mayne Pharma Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #090535
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-10 Sun Pharm Inds Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #090733
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-14 Vintage Pharms REMS Approved
Oxycodone and Acetaminophen
ANDA #090734
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-19 Vintage Pharms REMS Approved
Oxycodone and Acetaminophen
ANDA #201278
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-6 Rhodes Pharms REMS Approved
Oxycodone and Acetaminophen
ANDA #201447
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-14 Actavis Elizabeth REMS Approved
Oxycodone and Acetaminophen
ANDA #201972
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-11 Aurolife Pharma Llc REMS Approved
Oxycodone and Acetaminophen
ANDA #202677
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-10 Alvogen Malta REMS Approved
Oxycodone and Acetaminophen
ANDA #204407
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Novel Labs Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #207333
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-3 Lannett Co Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #207419
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Ascent Pharms Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #207510
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-1 Wes Pharma Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #207574
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-6 Chemo Research Sl REMS Approved
Oxycodone and Acetaminophen
ANDA #209385
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Elite Labs Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #210079
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-1 Nesher Pharms REMS Approved
Oxycodone and Acetaminophen
ANDA #210644
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-1 Abhai Llc REMS Approved
Oxycodone and Aspirin
ANDA #040255
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-27 Watson Labs REMS Approved
Oxycodone and Aspirin
ANDA #040260
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-15 Sun Pharm Industries REMS Approved
Oxycodone and Aspirin
ANDA #087794
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-27 Sun Pharm Industries REMS Approved
Oxycodone and Aspirin
ANDA #090084
Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-5 Actavis Labs Fl Inc REMS Approved
Oxycodone and Aspirin
ANDA #091670
Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Mayne Pharma Inc REMS Approved
Oxycodone Hydrochloride
ANDA #076636
Oxycodone Hydrochloride Tablet; Oral SUPPL-35 Actavis Elizabeth REMS Approved
Oxycodone Hydrochloride
ANDA #076758
Oxycodone Hydrochloride Tablet; Oral SUPPL-17 Specgx Llc REMS Approved
Oxycodone Hydrochloride
ANDA #077290
Oxycodone Hydrochloride Tablet; Oral SUPPL-24 Nesher Pharms REMS Approved
Oxycodone Hydrochloride
ANDA #077712
Oxycodone Hydrochloride Tablet; Oral SUPPL-24 Vintage Pharms REMS Approved
Oxycodone Hydrochloride
ANDA #090659
Oxycodone Hydrochloride Tablet; Oral SUPPL-18 Sun Pharm Inds Inc REMS Approved
Oxycodone Hydrochloride
ANDA #090895
Oxycodone Hydrochloride Tablet; Oral SUPPL-10 Epic Pharma Llc REMS Approved
Oxycodone Hydrochloride
ANDA #091313
Oxycodone Hydrochloride Tablet; Oral SUPPL-6 Mayne Pharma Inc REMS Approved
Oxycodone Hydrochloride
ANDA #091393
Oxycodone Hydrochloride Tablet; Oral SUPPL-15 Avanthi Inc REMS Approved
Oxycodone Hydrochloride
ANDA #091490
Oxycodone Hydrochloride Tablet; Oral SUPPL-5 Rhodes Pharms REMS Approved
Oxycodone Hydrochloride
NDA #200534
Oxycodone Hydrochloride Capsule; Oral SUPPL-8 Genus Lifesciences Labeling Approved
Oxycodone Hydrochloride
NDA #200534
Oxycodone Hydrochloride Capsule; Oral SUPPL-7 Genus Lifesciences REMS Approved
Oxycodone Hydrochloride
NDA #200535
Oxycodone Hydrochloride Solution; Oral SUPPL-15 Genus Lifesciences Labeling Approved
Oxycodone Hydrochloride
NDA #200535
Oxycodone Hydrochloride Solution; Oral SUPPL-14 Genus Lifesciences REMS Approved
Oxycodone Hydrochloride
NDA #201194
Oxycodone Hydrochloride Solution; Oral SUPPL-4 Vistapharm Labeling Approved
Oxycodone Hydrochloride
NDA #201194
Oxycodone Hydrochloride Solution; Oral SUPPL-4 Vistapharm Labeling Approved
Oxycodone Hydrochloride
NDA #201194
Oxycodone Hydrochloride Solution; Oral SUPPL-3 Vistapharm REMS Approved
Oxycodone Hydrochloride
ANDA #202116
Oxycodone Hydrochloride Tablet; Oral SUPPL-5 Alvogen Malta REMS Approved
Oxycodone Hydrochloride
ANDA #202160
Oxycodone Hydrochloride Tablet; Oral SUPPL-4 Aurolife Pharma Llc REMS Approved
Oxycodone Hydrochloride
ANDA #202537
Oxycodone Hydrochloride Solution; Oral SUPPL-2 Vistapharm REMS Approved
Oxycodone Hydrochloride
ANDA #202662
Oxycodone Hydrochloride Tablet; Oral SUPPL-5 Epic Pharma Llc REMS Approved
Oxycodone Hydrochloride
ANDA #202773
Oxycodone Hydrochloride Capsule; Oral SUPPL-2 Avanthi Inc REMS Approved
Oxycodone Hydrochloride
ANDA #203107
Oxycodone Hydrochloride Capsule; Oral SUPPL-2 Mayne Pharma Inc REMS Approved
Oxycodone Hydrochloride
ANDA #203208
Oxycodone Hydrochloride Solution; Oral SUPPL-4 West-Ward Pharms Int REMS Approved
Oxycodone Hydrochloride
ANDA #203447
Oxycodone Hydrochloride Solution; Oral SUPPL-2 Ani Pharms Inc REMS Approved
Oxycodone Hydrochloride
ANDA #203638
Oxycodone Hydrochloride Tablet; Oral SUPPL-3 Amneal Pharms REMS Approved
Oxycodone Hydrochloride
ANDA #203823
Oxycodone Hydrochloride Capsule; Oral SUPPL-7 Lannett Co Inc REMS Approved
Oxycodone Hydrochloride
ANDA #204021
Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Novel Labs Inc REMS Approved
Oxycodone Hydrochloride
ANDA #204037
Oxycodone Hydrochloride Solution; Oral SUPPL-7 West-Ward Pharms Int REMS Approved
Oxycodone Hydrochloride
ANDA #204085
Oxycodone Hydrochloride Solution; Oral SUPPL-4 Lannett Co Inc REMS Approved
Oxycodone Hydrochloride
ANDA #204092
Oxycodone Hydrochloride Solution; Oral SUPPL-3 Mayne Pharma Inc REMS Approved
Oxycodone Hydrochloride
ANDA #204603
Oxycodone Hydrochloride Solution; Oral SUPPL-3 Novel Labs Inc REMS Approved
Oxycodone Hydrochloride
ANDA #204752
Oxycodone Hydrochloride Capsule; Oral SUPPL-1 Novel Labs Inc REMS Approved
Oxycodone Hydrochloride
ANDA #204979
Oxycodone Hydrochloride Solution; Oral SUPPL-4 Ani Pharms Inc REMS Approved
Oxycodone Hydrochloride
ANDA #205177
Oxycodone Hydrochloride Capsule; Oral SUPPL-4 Ani Pharms Inc REMS Approved
Oxycodone Hydrochloride
ANDA #206456
Oxycodone Hydrochloride Solution; Oral SUPPL-3 Wockhardt Bio Ag REMS Approved
Oxycodone Hydrochloride
ANDA #206822
Oxycodone Hydrochloride Solution; Oral SUPPL-1 Pharm Assoc REMS Approved
Oxycodone Hydrochloride
ANDA #207119
Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Ken Lifescience REMS Approved
Oxycodone Hydrochloride
ANDA #207418
Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Ascent Pharms Inc REMS Approved
Oxycodone Hydrochloride
ANDA #207511
Oxycodone Hydrochloride Solution; Oral SUPPL-3 Wes Pharma Inc REMS Approved
Oxycodone Hydrochloride
ANDA #208593
Oxycodone Hydrochloride Solution; Oral SUPPL-1 Abhai Llc REMS Approved
Oxycodone Hydrochloride
ANDA #208795
Oxycodone Hydrochloride Solution; Oral SUPPL-1 Hi-Tech Pharmacal REMS Approved
Oxycodone Hydrochloride
ANDA #208817
Oxycodone Hydrochloride Solution; Oral SUPPL-1 Hi-Tech Pharmacal REMS Approved
Oxycodone Hydrochloride
ANDA #209021
Oxycodone Hydrochloride Solution; Oral SUPPL-2 Ascent Pharms Inc REMS Approved
Oxycodone Hydrochloride
ANDA #209897
Oxycodone Hydrochloride Solution; Oral SUPPL-1 Wes Pharma Inc REMS Approved
Oxycodone Hydrochloride and Acetaminophen
ANDA #203573
Acetaminophen; Oxycodone Hydrochloride Solution; Oral SUPPL-6 Vintage Pharms REMS Approved
Oxycodone Hydrochloride and Ibuprofen
ANDA #078316
Ibuprofen; Oxycodone Hydrochloride Tablet; Oral SUPPL-8 Barr Labs Inc REMS Approved
Oxycodone Hydrochloride and Ibuprofen
ANDA #078394
Ibuprofen; Oxycodone Hydrochloride Tablet; Oral SUPPL-15 Watson Labs REMS Approved
Oxycodone Hydrochloride and Ibuprofen
ANDA #078769
Ibuprofen; Oxycodone Hydrochloride Tablet; Oral SUPPL-22 Actavis Elizabeth REMS Approved
Oxycontin
NDA #022272
Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-41 Purdue Pharma Lp Labeling Approved
Oxycontin
NDA #022272
Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-40 Purdue Pharma Lp REMS Approved
Oxymorphone Hydrochloride
ANDA #079046
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-28 Actavis Elizabeth REMS Approved
Oxymorphone Hydrochloride
ANDA #079087
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-32 Impax Labs REMS Approved
Oxymorphone Hydrochloride
ANDA #090964
Oxymorphone Hydrochloride Tablet; Oral SUPPL-6 West-Ward Pharms Int REMS Approved
Oxymorphone Hydrochloride
ANDA #091443
Oxymorphone Hydrochloride Tablet; Oral SUPPL-9 Teva REMS Approved
Oxymorphone Hydrochloride
ANDA #200822
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-12 West-Ward Pharms Int REMS Approved
Oxymorphone Hydrochloride
ANDA #201187
Oxymorphone Hydrochloride Tablet; Oral SUPPL-4 Epic Pharma Llc REMS Approved
Oxymorphone Hydrochloride
ANDA #202321
Oxymorphone Hydrochloride Tablet; Oral SUPPL-3 Specgx Llc REMS Approved
Oxymorphone Hydrochloride
ANDA #202946
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Specgx Llc REMS Approved
Oxymorphone Hydrochloride
ANDA #203601
Oxymorphone Hydrochloride Tablet; Oral SUPPL-5 Avanthi Inc REMS Approved
Oxymorphone Hydrochloride
ANDA #204459
Oxymorphone Hydrochloride Tablet; Oral SUPPL-2 Aurolife Pharma Llc REMS Approved
Oxymorphone Hydrochloride
ANDA #210175
Oxymorphone Hydrochloride Tablet; Oral SUPPL-2 Ascent Pharms Inc REMS Approved
Percocet
ANDA #040330
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-50 Vintage Pharms Llc REMS Approved
Percocet
ANDA #085106
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-27 Vintage Pharms Llc REMS Approved
Percodan
NDA #007337
Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-51 Endo Pharms Labeling Approved
Percodan
NDA #007337
Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-50 Endo Pharms REMS Approved
Percodan
NDA #007337
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-51 Endo Pharms Labeling Approved
Percodan
NDA #007337
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-50 Endo Pharms REMS Approved
Percodan-Demi
NDA #007337
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-51 Endo Pharms Labeling Approved
Percodan-Demi
NDA #007337
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-50 Endo Pharms REMS Approved
Reprexain
ANDA #076642
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-25 Amneal Pharms Ny REMS Approved
Roxicet
ANDA #087003
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-41 West-Ward Pharms Int REMS Approved
Roxicet
ANDA #089351
Acetaminophen; Oxycodone Hydrochloride Solution; Oral SUPPL-29 West-Ward Pharms Int REMS Approved
Roxicodone
NDA #021011
Oxycodone Hydrochloride Tablet; Oral SUPPL-9 Specgx Llc Labeling Approved
Roxicodone
NDA #021011
Oxycodone Hydrochloride Tablet; Oral SUPPL-8 Specgx Llc REMS Approved
Roxybond
NDA #209777
Oxycodone Hydrochloride Tablet; Oral SUPPL-3 Daiichi Sankyo Inc Labeling Approved
Roxybond
NDA #209777
Oxycodone Hydrochloride Tablet; Oral SUPPL-3 Daiichi Sankyo Inc Labeling Approved
Roxybond
NDA #209777
Oxycodone Hydrochloride Tablet; Oral SUPPL-1 Daiichi Sankyo Inc REMS Approved
Synalgos-Dc
NDA #011483
Aspirin; Caffeine; Dihydrocodeine Bitartrate Capsule; Oral SUPPL-32 Sun Pharm Industries Labeling Approved
Synalgos-Dc
NDA #011483
Aspirin; Caffeine; Dihydrocodeine Bitartrate Capsule; Oral SUPPL-31 Sun Pharm Industries REMS Approved
Targiniq
NDA #205777
Naloxone Hydrochloride; Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-11 Purdue Pharma Lp Labeling Approved
Targiniq
NDA #205777
Naloxone Hydrochloride; Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Purdue Pharma Lp REMS Approved
Tetracycline Hydrochloride
ANDA #210674
Tetracycline Hydrochloride Capsule; Oral ORIG-1 Amneal Pharms Ny Approved
Tramadol Hydrochloride
ANDA #075962
Tramadol Hydrochloride Tablet; Oral SUPPL-9 Watson Labs REMS Approved
Tramadol Hydrochloride
ANDA #075964
Tramadol Hydrochloride Tablet; Oral SUPPL-31 Sun Pharm Inds Inc REMS Approved
Tramadol Hydrochloride
ANDA #075968
Tramadol Hydrochloride Tablet; Oral SUPPL-11 Fosun Pharma REMS Approved
Tramadol Hydrochloride
ANDA #075977
Tramadol Hydrochloride Tablet; Oral SUPPL-17 Teva REMS Approved
Tramadol Hydrochloride
ANDA #075980
Tramadol Hydrochloride Tablet; Oral SUPPL-4 Mylan Pharms Inc REMS Approved
Tramadol Hydrochloride
ANDA #075981
Tramadol Hydrochloride Tablet; Oral SUPPL-18 Apotex REMS Approved
Tramadol Hydrochloride
ANDA #075982
Tramadol Hydrochloride Tablet; Oral SUPPL-14 Pliva REMS Approved
Tramadol Hydrochloride
ANDA #075983
Tramadol Hydrochloride Tablet; Oral SUPPL-12 Specgx Llc REMS Approved
Tramadol Hydrochloride
ANDA #075986
Tramadol Hydrochloride Tablet; Oral SUPPL-18 Mylan REMS Approved
Tramadol Hydrochloride
ANDA #076003
Tramadol Hydrochloride Tablet; Oral SUPPL-37 Amneal Pharms REMS Approved
Tramadol Hydrochloride
ANDA #076100
Tramadol Hydrochloride Tablet; Oral SUPPL-23 Sun Pharm Industries REMS Approved
Tramadol Hydrochloride
ANDA #078783
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Par Pharm Inc REMS Approved
Tramadol Hydrochloride
ANDA #090404
Tramadol Hydrochloride Tablet; Oral SUPPL-8 Zydus Pharms Usa Inc REMS Approved
Tramadol Hydrochloride
ANDA #091498
Tramadol Hydrochloride Tablet; Oral SUPPL-7 Cspc Ouyi Pharm Co REMS Approved
Tramadol Hydrochloride
ANDA #091607
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-14 Sun Pharma Global REMS Approved
Tramadol Hydrochloride
ANDA #091609
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-7 Actavis Elizabeth REMS Approved
Tramadol Hydrochloride
ANDA #200491
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Anchen Pharms REMS Approved
Tramadol Hydrochloride
ANDA #200503
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-7 Lupin Ltd REMS Approved
Tramadol Hydrochloride
ANDA #201384
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-12 Sun Pharma Global REMS Approved
Tramadol Hydrochloride
ANDA #201973
Tramadol Hydrochloride Tablet; Oral SUPPL-3 Ipca Labs Ltd REMS Approved
Tramadol Hydrochloride
ANDA #203494
Tramadol Hydrochloride Tablet; Oral SUPPL-8 Aurobindo Pharma Ltd REMS Approved
Tramadol Hydrochloride
ANDA #204421
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-6 Aurobindo Pharma Ltd REMS Approved
Tramadol Hydrochloride
ANDA #205257
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-6 Mylan Pharms Inc REMS Approved
Tramadol Hydrochloride
ANDA #205702
Tramadol Hydrochloride Tablet; Oral SUPPL-7 Macleods Pharms Ltd REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #076475
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-19 Par Pharm REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #076914
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-6 Cspc Ouyi Pharm Co REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #077184
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-15 Sun Pharm Inds Inc REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #077858
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-7 Mylan REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #078778
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-7 Apotex Inc REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #090460
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-9 Zydus Pharms Usa Inc REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #090485
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-16 Amneal Pharms REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #201952
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-9 Micro Labs Ltd India REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #202076
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-3 Alkem Labs Ltd REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #206885
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-10 Macleods Pharms Ltd REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #207152
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-4 Aurobindo Pharma Ltd REMS Approved
Tylenol W/ Codeine No. 1
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-60 Janssen Pharms REMS Approved
Tylenol W/ Codeine No. 2
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-60 Janssen Pharms REMS Approved
Tylenol W/ Codeine No. 3
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-60 Janssen Pharms REMS Approved
Tylenol W/ Codeine No. 4
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-60 Janssen Pharms REMS Approved
Ultracet
NDA #021123
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-17 Janssen Pharms Labeling Approved
Ultracet
NDA #021123
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-16 Janssen Pharms REMS Approved
Ultram
NDA #020281
Tramadol Hydrochloride Tablet; Oral SUPPL-43 Janssen Pharms Labeling Approved
Ultram
NDA #020281
Tramadol Hydrochloride Tablet; Oral SUPPL-42 Janssen Pharms REMS Approved
Xartemis Xr
NDA #204031
Acetaminophen; Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Mallinckrodt Inc Labeling Approved
Xartemis Xr
NDA #204031
Acetaminophen; Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-4 Mallinckrodt Inc REMS Approved
Xtampza Er
NDA #208090
Oxycodone Capsule, Extended Release; Oral SUPPL-10 Collegium Pharm Inc Labeling Approved
Xtampza Er
NDA #208090
Oxycodone Capsule, Extended Release; Oral SUPPL-8 Collegium Pharm Inc REMS Approved
Zohydro Er
NDA #202880
Hydrocodone Bitartrate Capsule, Extended Release; Oral SUPPL-15 Pernix Ireland Pain Labeling Approved
Zohydro Er
NDA #202880
Hydrocodone Bitartrate Capsule, Extended Release; Oral SUPPL-14 Pernix Ireland Pain REMS Approved

September 17, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ritonavir
ANDA #204587
Ritonavir Tablet; Oral ORIG-1 Hetero Labs Ltd Iii Approved
Ritonavir
ANDA #206614
Ritonavir Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Ritonavir
ANDA #208890
Ritonavir Tablet; Oral ORIG-1 Amneal Pharms Llc Approved

September 14, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ajovy
BLA #761089
Fremanezumab-Vfrm Injectable; Injection ORIG-1 Teva Pharms Usa Type 1 - New Molecular Entity Approved
Ambien
NDA #019908
Zolpidem Tartrate Tablet; Oral SUPPL-42 Sanofi Aventis Us Labeling Approved
Ambien Cr
NDA #021774
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-23 Sanofi Aventis Us Labeling Approved
Clofarabine
ANDA #210270
Clofarabine Solution; Intravenous ORIG-1 Ingenus Pharms Llc Approved
Eplerenone
ANDA #208283
Eplerenone Tablet; Oral ORIG-1 Breckenridge Pharm Approved
Estradiol
ANDA #210264
Estradiol Tablet; Vaginal ORIG-1 Glenmark Pharms Ltd Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077723
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-19 Vintage Pharms Labeling Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077723
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-19 Vintage Pharms Labeling Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077727
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-15 Vintage Pharms Labeling Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077727
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-15 Vintage Pharms Labeling Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #091633
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-8 Sun Pharm Inds Inc Labeling Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #091633
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-3 Sun Pharm Inds Inc Labeling Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #091633
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-8 Sun Pharm Inds Inc Labeling Approved
Ingenol Mebutate
ANDA #209019
Ingenol Mebutate Gel; Topical ORIG-1 Perrigo Uk Finco Tentative Approval
Levoleucovorin Calcium
ANDA #210892
Levoleucovorin Calcium Solution; Intravenous ORIG-1 Gland Pharma Ltd Approved
Magnesium Sulfate In Plastic Container
ANDA #209911
Magnesium Sulfate Injectable; Injection ORIG-1 Mylan Labs Ltd Approved
Novothyrox
NDA #021292
Levothyroxine Sodium Tablet; Oral SUPPL-4 Merck Kgaa Efficacy Approved
Novothyrox
NDA #021292
Levothyroxine Sodium Tablet; Oral SUPPL-5 Merck Kgaa Labeling Approved
Novothyrox
NDA #021292
Levothyroxine Sodium Tablet; Oral SUPPL-6 Merck Kgaa Labeling Approved
Seizalam
NDA #209566
Midazolam Injectable; Injection ORIG-1 Meridian Medcl Techn Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approved
Silodosin
ANDA #211060
Silodosin Unknown ORIG-1 Ajanta Pharma Ltd Tentative Approval
Sodium Chloride 3% In Plastic Container
NDA #019022
Sodium Chloride Injectable; Injection SUPPL-31 Baxter Hlthcare Labeling Approved
Sodium Chloride 5% In Plastic Container
NDA #019022
Sodium Chloride Injectable; Injection SUPPL-31 Baxter Hlthcare Labeling Approved
Solifenacin Succinate
ANDA #210688
Solifenacin Succinate Unknown ORIG-1 Msn Labs Pvt Ltd Tentative Approval
Syndros
NDA #205525
Dronabinol Solution; Oral SUPPL-7 Insys Dev Co Inc Labeling Approved

September 13, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Hydrocodone Bitartrate and Acetaminophen
ANDA #207709
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral ORIG-1 Aurolife Pharma Llc Approved
Lansoprazole
ANDA #200816
Lansoprazole Unknown ORIG-1 Zydus Pharms Usa Inc Tentative Approval
Lumoxiti
BLA #761104
Moxetumomab Pasudotox-Tdfk Injectable; Injection ORIG-1 Astrazeneca Ab Type 1 - New Molecular Entity Approved

September 12, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Actemra
BLA #125276
Tocilizumab Injectable; Injection SUPPL-122 Genentech Labeling Approved
Actemra
BLA #125472
Tocilizumab Injectable; Intravenous, Subcutaneous SUPPL-31 Genentech Efficacy Approved
Botox
BLA #103000
Onabotulinumtoxina Vial; Single-Use SUPPL-5308 Allergan Efficacy Approved
Botox Cosmetic
BLA #103000
Onabotulinumtoxina Vial; Single-Use SUPPL-5308 Allergan Efficacy Approved
Caduet
NDA #021540
Amlodipine Besylate; Atorvastatin Calcium Tablet; Oral SUPPL-42 Pfizer Labeling Approved
Caduet
NDA #021540
Amlodipine Besylate; Atorvastatin Calcium Tablet; Oral SUPPL-43 Pfizer Labeling Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #202214
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Tris Pharma Inc Labeling Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #202214
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Tris Pharma Inc Labeling Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #202214
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-7 Tris Pharma Inc Labeling Approved
Invanz
NDA #021337
Ertapenem Sodium Injectable; Intramuscular, Iv (Infusion) SUPPL-46 Merck Sharp Dohme Labeling Approved
Spritam
NDA #207958
Levetiracetam Tablet, For Suspension; Oral SUPPL-8 Aprecia Pharms Labeling Approved
Spritam
NDA #207958
Levetiracetam Tablet, For Suspension; Oral SUPPL-8 Aprecia Pharms Labeling Approved
Tranexamic Acid
ANDA #202755
Tranexamic Acid Injectable; Injection SUPPL-1 Virtus Pharms Manufacturing (CMC) Approved
Xelpros
NDA #206185
Latanoprost Emulsion; Ophthalmic ORIG-1 Sun Pharma Global Type 3 - New Dosage Form Approved

September 11, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atovaquone
ANDA #209105
Atovaquone Suspension; Oral ORIG-1 Lupin Ltd Approved
Carmustine
ANDA #210179
Carmustine Injectable; Injection ORIG-1 Navinta Llc Approved
Dimethyl Fumarate
ANDA #210440
Dimethyl Fumarate Unknown ORIG-1 Alkem Labs Ltd Tentative Approval
Hydrocodone Bitartrate and Acetaminophen
ANDA #206142
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-3 Novel Labs Inc Labeling Approved
Oxycodone and Aspirin
ANDA #090084
Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-6 Actavis Labs Fl Inc Labeling Approved
Oxycodone and Aspirin
ANDA #090084
Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-6 Actavis Labs Fl Inc Labeling Approved
Risedronate Sodium
ANDA #203822
Risedronate Sodium Tablet, Delayed Release; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Tramadol Hydrochloride
ANDA #204421
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Aurobindo Pharma Ltd Labeling Approved
Tramadol Hydrochloride
ANDA #204421
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Aurobindo Pharma Ltd Labeling Approved

September 18, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetaminophen and Codeine Phosphate
ANDA #040119
Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-13 Hi Tech Pharma REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #040419
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-24 Specgx Llc REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #040779
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-19 Amneal Pharms Ny REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #081249
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-11 Fosun Pharma REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #081250
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-11 Fosun Pharma REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #085861
Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-77 Actavis Mid Atlantic REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #085868
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-63 Sun Pharm Inds Ltd REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #087006
Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-33 Wockhardt Bio Ag REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #087083
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-50 Sun Pharm Inds Ltd REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #087508
Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-43 Pharm Assoc REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #088627
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-60 Teva REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #088628
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-69 Teva REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #088629
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-68 Teva REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089450
Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-24 Mikart REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089805
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-31 Vintage REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089828
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-29 Vintage Pharms REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089990
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-26 Vintage REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089997
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-21 Watson Labs REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089998
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-21 Watson Labs REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #089999
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-20 Watson Labs REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #091238
Acetaminophen; Codeine Phosphate Solution; Oral SUPPL-15 Lannett Co Inc REMS Approved
Acetaminophen and Codeine Phosphate
ANDA #202800
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-9 Aurolife Pharma Llc REMS Approved
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate
ANDA #204209
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate Tablet; Oral SUPPL-7 Larken Labs Inc REMS Approved
Anexsia 5/325
ANDA #040409
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-27 Specgx Llc REMS Approved
Anexsia 7.5/325
ANDA #040405
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-27 Specgx Llc REMS Approved
Apadaz
NDA #208653
Acetaminophen; Benzhydrocodone Hydrochloride Tablet; Oral SUPPL-2 Kempharm Labeling Approved
Apadaz
NDA #208653
Acetaminophen; Benzhydrocodone Hydrochloride Tablet; Oral SUPPL-3 Kempharm REMS Approved
Arymo Er
NDA #208603
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-4 Egalet Labeling Approved
Arymo Er
NDA #208603
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-3 Egalet REMS Approved
Belbuca
NDA #207932
Buprenorphine Hydrochloride Film; Buccal SUPPL-9 Bdsi Labeling Approved
Belbuca
NDA #207932
Buprenorphine Hydrochloride Film; Buccal SUPPL-9 Bdsi Labeling Approved
Belbuca
NDA #207932
Buprenorphine Hydrochloride Film; Buccal SUPPL-8 Bdsi REMS Approved
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
ANDA #075618
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-27 Hikma Intl Pharms REMS Approved
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
ANDA #075929
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-24 Vintage Pharms REMS Approved
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
ANDA #076560
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-8 Nexgen Pharma Inc REMS Approved
Butalbital, Aspirin, Caffeine and Codeine Phosphate
ANDA #203335
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-5 Mayne Pharma Inc REMS Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #074359
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-14 Watson Labs REMS Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #074951
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-4 Stevens J REMS Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #075231
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-8 Nexgen Pharma Inc REMS Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #075351
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-5 Vintage Pharms Llc REMS Approved
Butorphanol Tartrate
ANDA #075499
Butorphanol Tartrate Spray, Metered; Nasal SUPPL-24 Apotex Inc REMS Approved
Butorphanol Tartrate
ANDA #075759
Butorphanol Tartrate Spray, Metered; Nasal SUPPL-28 Mylan REMS Approved
Butorphanol Tartrate
ANDA #075824
Butorphanol Tartrate Spray, Metered; Nasal SUPPL-11 West-Ward Pharms Int REMS Approved
Butrans
NDA #021306
Buprenorphine Film, Extended Release; Transdermal SUPPL-34 Purdue Pharma Lp Labeling Approved
Butrans
NDA #021306
Buprenorphine Film, Extended Release; Transdermal SUPPL-34 Purdue Pharma Lp Labeling Approved
Butrans
NDA #021306
Buprenorphine Film, Extended Release; Transdermal SUPPL-32 Purdue Pharma Lp REMS Approved
Carisoprodol, Aspirin and Codeine Phosphate
ANDA #040118
Aspirin; Carisoprodol; Codeine Phosphate Tablet; Oral SUPPL-17 Sandoz REMS Approved
Carisoprodol, Aspirin and Codeine Phosphate
ANDA #040860
Aspirin; Carisoprodol; Codeine Phosphate Tablet; Oral SUPPL-3 Ingenus Pharms Nj REMS Approved
Codeine Sulfate
NDA #022402
Codeine Sulfate Tablet; Oral SUPPL-11 West-Ward Pharms Int Labeling Approved
Codeine Sulfate
NDA #022402
Codeine Sulfate Tablet; Oral SUPPL-10 West-Ward Pharms Int REMS Approved
Codeine Sulfate
NDA #202245
Codeine Sulfate Solution; Oral SUPPL-7 West-Ward Pharms Int Labeling Approved
Codeine Sulfate
NDA #202245
Codeine Sulfate Solution; Oral SUPPL-6 West-Ward Pharms Int REMS Approved
Codeine Sulfate
ANDA #203046
Codeine Sulfate Tablet; Oral SUPPL-7 Lannett Co Inc REMS Approved
Conzip
NDA #022370
Tramadol Hydrochloride Capsule, Extended Release; Oral SUPPL-17 Cipher Pharms Inc Labeling Approved
Conzip
NDA #022370
Tramadol Hydrochloride Capsule, Extended Release; Oral SUPPL-16 Cipher Pharms Inc REMS Approved
Demerol
NDA #005010
Meperidine Hydrochloride Injectable; Injection SUPPL-57 Us Pharm Holdings Labeling Approved
Demerol
NDA #005010
Meperidine Hydrochloride Injectable; Injection SUPPL-56 Us Pharm Holdings REMS Approved
Demerol
NDA #005010
Meperidine Hydrochloride Syrup; Oral SUPPL-57 Us Pharm Holdings Labeling Approved
Demerol
NDA #005010
Meperidine Hydrochloride Syrup; Oral SUPPL-56 Us Pharm Holdings REMS Approved
Demerol
NDA #005010
Meperidine Hydrochloride Tablet; Oral SUPPL-57 Us Pharm Holdings Labeling Approved
Demerol
NDA #005010
Meperidine Hydrochloride Tablet; Oral SUPPL-56 Us Pharm Holdings REMS Approved
Dilaudid
NDA #019891
Hydromorphone Hydrochloride Solution; Oral SUPPL-27 Rhodes Pharms Labeling Approved
Dilaudid
NDA #019891
Hydromorphone Hydrochloride Solution; Oral SUPPL-26 Rhodes Pharms REMS Approved
Dilaudid
NDA #019892
Hydromorphone Hydrochloride Tablet; Oral SUPPL-34 Rhodes Pharms Labeling Approved
Dilaudid
NDA #019892
Hydromorphone Hydrochloride Tablet; Oral SUPPL-33 Rhodes Pharms REMS Approved
Dolophine Hydrochloride
NDA #006134
Methadone Hydrochloride Syrup; Oral SUPPL-48 West-Ward Pharms Int Labeling Approved
Dolophine Hydrochloride
NDA #006134
Methadone Hydrochloride Syrup; Oral SUPPL-46 West-Ward Pharms Int REMS Approved
Dolophine Hydrochloride
NDA #006134
Methadone Hydrochloride Tablet; Oral SUPPL-48 West-Ward Pharms Int Labeling Approved
Dolophine Hydrochloride
NDA #006134
Methadone Hydrochloride Tablet; Oral SUPPL-46 West-Ward Pharms Int REMS Approved
Duragesic-100
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-76 Janssen Pharms Labeling Approved
Duragesic-100
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-75 Janssen Pharms REMS Approved
Duragesic-12
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-76 Janssen Pharms Labeling Approved
Duragesic-12
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-75 Janssen Pharms REMS Approved
Duragesic-25
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-76 Janssen Pharms Labeling Approved
Duragesic-25
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-75 Janssen Pharms REMS Approved
Duragesic-37
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-76 Janssen Pharms Labeling Approved
Duragesic-37
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-75 Janssen Pharms REMS Approved
Duragesic-50
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-76 Janssen Pharms Labeling Approved
Duragesic-50
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-75 Janssen Pharms REMS Approved
Duragesic-75
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-76 Janssen Pharms Labeling Approved
Duragesic-75
NDA #019813
Fentanyl Film, Extended Release; Transdermal SUPPL-75 Janssen Pharms REMS Approved
Embeda
NDA #022321
Morphine Sulfate; Naltrexone Hydrochloride Capsule, Extended Release; Oral SUPPL-29 Alpharma Pharms Labeling Approved
Embeda
NDA #022321
Morphine Sulfate; Naltrexone Hydrochloride Capsule, Extended Release; Oral SUPPL-28 Alpharma Pharms REMS Approved
Exalgo
NDA #021217
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-24 Specgx Llc Labeling Approved
Exalgo
NDA #021217
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-23 Specgx Llc REMS Approved
Fentanyl-100
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-100
ANDA #076709
Fentanyl Film, Extended Release; Transdermal SUPPL-31 Actavis Labs Ut Inc REMS Approved
Fentanyl-100
ANDA #077062
Fentanyl Film, Extended Release; Transdermal SUPPL-38 Mayne Pharma REMS Approved
Fentanyl-100
ANDA #077154
Fentanyl Film, Extended Release; Transdermal SUPPL-20 Specgx Llc REMS Approved
Fentanyl-100
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-100
ANDA #202097
Fentanyl Film, Extended Release; Transdermal SUPPL-4 3m Drug Delivery REMS Approved
Fentanyl-12
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-12
ANDA #077154
Fentanyl Film, Extended Release; Transdermal SUPPL-20 Specgx Llc REMS Approved
Fentanyl-12
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-12
ANDA #202097
Fentanyl Film, Extended Release; Transdermal SUPPL-4 3m Drug Delivery REMS Approved
Fentanyl-25
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-25
ANDA #076709
Fentanyl Film, Extended Release; Transdermal SUPPL-31 Actavis Labs Ut Inc REMS Approved
Fentanyl-25
ANDA #077062
Fentanyl Film, Extended Release; Transdermal SUPPL-38 Mayne Pharma REMS Approved
Fentanyl-25
ANDA #077154
Fentanyl Film, Extended Release; Transdermal SUPPL-20 Specgx Llc REMS Approved
Fentanyl-25
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-25
ANDA #202097
Fentanyl Film, Extended Release; Transdermal SUPPL-4 3m Drug Delivery REMS Approved
Fentanyl-37
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-37
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-50
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-50
ANDA #076709
Fentanyl Film, Extended Release; Transdermal SUPPL-31 Actavis Labs Ut Inc REMS Approved
Fentanyl-50
ANDA #077062
Fentanyl Film, Extended Release; Transdermal SUPPL-38 Mayne Pharma REMS Approved
Fentanyl-50
ANDA #077154
Fentanyl Film, Extended Release; Transdermal SUPPL-20 Specgx Llc REMS Approved
Fentanyl-50
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-50
ANDA #202097
Fentanyl Film, Extended Release; Transdermal SUPPL-4 3m Drug Delivery REMS Approved
Fentanyl-62
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-62
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-75
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-75
ANDA #076709
Fentanyl Film, Extended Release; Transdermal SUPPL-31 Actavis Labs Ut Inc REMS Approved
Fentanyl-75
ANDA #077062
Fentanyl Film, Extended Release; Transdermal SUPPL-38 Mayne Pharma REMS Approved
Fentanyl-75
ANDA #077154
Fentanyl Film, Extended Release; Transdermal SUPPL-20 Specgx Llc REMS Approved
Fentanyl-75
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fentanyl-75
ANDA #202097
Fentanyl Film, Extended Release; Transdermal SUPPL-4 3m Drug Delivery REMS Approved
Fentanyl-87
ANDA #076258
Fentanyl Film, Extended Release; Transdermal SUPPL-37 Mylan Technologies REMS Approved
Fentanyl-87
ANDA #077449
Fentanyl Film, Extended Release; Transdermal SUPPL-26 Aveva REMS Approved
Fioricet W/ Codeine
NDA #020232
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-43 Actavis Labs Ut Inc Labeling Approved
Fioricet W/ Codeine
NDA #020232
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-42 Actavis Labs Ut Inc REMS Approved
Fiorinal W/Codeine
NDA #019429
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-42 Allergan Sales Llc Labeling Approved
Fiorinal W/Codeine
NDA #019429
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-41 Allergan Sales Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040148
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-71 Apil REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040248
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Watson Labs REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040355
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-35 Vintage Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040400
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-27 Specgx Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040432
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-11 Mikart REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040482
Acetaminophen; Hydrocodone Bitartrate Solution; Oral SUPPL-19 Mikart REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040655
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-25 Vintage Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040656
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-25 Vintage Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040658
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-12 Mikart REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040736
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-18 Amneal Pharms Ny REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040746
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-20 Amneal Pharms Ny REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040826
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-9 Sun Pharm Inds Ltd REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040834
Acetaminophen; Hydrocodone Bitartrate Solution; Oral SUPPL-12 Pharm Assoc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040838
Acetaminophen; Hydrocodone Bitartrate Solution; Oral SUPPL-11 Pharm Assoc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040846
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-11 Mikart REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040881
Acetaminophen; Hydrocodone Bitartrate Solution; Oral SUPPL-10 Mikart REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040894
Acetaminophen; Hydrocodone Bitartrate Solution; Oral SUPPL-10 Genus Lifesciences REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #090118
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-27 Sun Pharm Inds Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #090415
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-16 Vintage Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #200343
Acetaminophen; Hydrocodone Bitartrate Solution; Oral SUPPL-4 Vistapharm REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #201013
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-11 Aurolife Pharma Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #202214
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-8 Tris Pharma Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #202935
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-3 Par Pharm REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #202991
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-4 Rhodes Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #203863
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Epic Pharma Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #205001
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-2 Par Pharm REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #206142
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-2 Novel Labs Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #206245
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Novel Labs Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #206470
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Actavis Labs Fl Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #206484
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Upsher-Smith Labs REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #206718
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Specgx Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #206869
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Amneal Pharms Ny REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207137
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-2 Amneal Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207171
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-2 Lannett Co Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207172
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-2 Lannett Co Inc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207709
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Aurolife Pharma Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207808
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Rhodes Pharms REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #209036
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Abhai Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #209037
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Abhai Llc REMS Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #210211
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Wes Pharma Inc REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #076023
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-19 Teva REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #076604
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-20 Actavis Labs Fl Inc REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #076642
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-25 Amneal Pharms Ny REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077454
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-3 Actavis Labs Fl Inc REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077723
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-21 Vintage Pharms REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077727
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-17 Vintage Pharms REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #091633
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-7 Sun Pharm Inds Inc REMS Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #204575
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-2 Aurolife Pharma Llc REMS Approved
Hydromorphone Hydrochloride
ANDA #074597
Hydromorphone Hydrochloride Tablet; Oral SUPPL-15 West-Ward Pharms Int REMS Approved
Hydromorphone Hydrochloride
ANDA #074653
Hydromorphone Hydrochloride Solution; Oral SUPPL-9 West-Ward Pharms Int REMS Approved
Hydromorphone Hydrochloride
ANDA #076723
Hydromorphone Hydrochloride Tablet; Oral SUPPL-8 Elite Labs REMS Approved
Hydromorphone Hydrochloride
ANDA #076855
Hydromorphone Hydrochloride Tablet; Oral SUPPL-13 Specgx Llc REMS Approved
Hydromorphone Hydrochloride
ANDA #077471
Hydromorphone Hydrochloride Tablet; Oral SUPPL-12 Lannett Co Inc REMS Approved
Hydromorphone Hydrochloride
ANDA #202144
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-15 Actavis Labs Fl Inc REMS Approved
Hydromorphone Hydrochloride
ANDA #204278
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-12 Paddock Llc REMS Approved
Hydromorphone Hydrochloride
ANDA #205629
Hydromorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-6 Osmotica REMS Approved
Hydromorphone Hydrochloride
ANDA #205814
Hydromorphone Hydrochloride Tablet; Oral SUPPL-2 Aurolife Pharma Llc REMS Approved
Hydromorphone Hydrochloride
ANDA #210176
Hydromorphone Hydrochloride Solution; Oral SUPPL-2 Ascent Pharms Inc REMS Approved
Hydromorphone Hydrochloride
ANDA #210506
Hydromorphone Hydrochloride Tablet; Oral SUPPL-2 Ascent Pharms Inc REMS Approved
Hysingla
NDA #206627
Hydrocodone Bitartrate Tablet, Extended Release; Oral SUPPL-8 Purdue Pharma Lp Labeling Approved
Hysingla
NDA #206627
Hydrocodone Bitartrate Tablet, Extended Release; Oral SUPPL-8 Purdue Pharma Lp Labeling Approved
Hysingla
NDA #206627
Hydrocodone Bitartrate Tablet, Extended Release; Oral SUPPL-7 Purdue Pharma Lp REMS Approved
Kadian
NDA #020616
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-62 Allergan Sales Llc Labeling Approved
Kadian
NDA #020616
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-61 Allergan Sales Llc REMS Approved
Levorphanol Tartrate
ANDA #074278
Levorphanol Tartrate Tablet; Oral SUPPL-12 Sentynl Theraps Inc REMS Approved
Meperidine Hydrochloride
ANDA #040110
Meperidine Hydrochloride Tablet; Oral SUPPL-6 West-Ward Pharms Int REMS Approved
Meperidine Hydrochloride
ANDA #040186
Meperidine Hydrochloride Tablet; Oral SUPPL-9 Watson Labs REMS Approved
Meperidine Hydrochloride
ANDA #040191
Meperidine Hydrochloride Tablet; Oral SUPPL-14 Vintage Pharms REMS Approved
Meperidine Hydrochloride
ANDA #040331
Meperidine Hydrochloride Tablet; Oral SUPPL-16 Epic Pharma REMS Approved
Meperidine Hydrochloride
ANDA #040352
Meperidine Hydrochloride Tablet; Oral SUPPL-5 Specgx Llc REMS Approved
Meperidine Hydrochloride
ANDA #040446
Meperidine Hydrochloride Tablet; Oral SUPPL-11 Sun Pharm Inds Inc REMS Approved
Meperidine Hydrochloride
ANDA #040893
Meperidine Hydrochloride Tablet; Oral SUPPL-4 Mikart REMS Approved
Meperidine Hydrochloride
ANDA #080448
Meperidine Hydrochloride Tablet; Oral SUPPL-21 Sun Pharm Industries REMS Approved
Meperidine Hydrochloride
ANDA #088639
Meperidine Hydrochloride Tablet; Oral SUPPL-40 Barr REMS Approved
Meperidine Hydrochloride
ANDA #088640
Meperidine Hydrochloride Tablet; Oral SUPPL-42 Barr REMS Approved
Meperidine Hydrochloride
ANDA #088744
Meperidine Hydrochloride Syrup; Oral SUPPL-27 West-Ward Pharms Int REMS Approved
Methadone Hydrochloride
ANDA #040241
Methadone Hydrochloride Tablet; Oral SUPPL-19 Sandoz REMS Approved
Methadone Hydrochloride
ANDA #040517
Methadone Hydrochloride Tablet; Oral SUPPL-25 Specgx Llc REMS Approved
Methadone Hydrochloride
ANDA #075082
Methadone Hydrochloride Tablet, For Suspension; Oral SUPPL-8 Sandoz REMS Approved
Methadone Hydrochloride
ANDA #077142
Methadone Hydrochloride Tablet, For Suspension; Oral SUPPL-17 Specgx Llc REMS Approved
Methadone Hydrochloride
ANDA #087393
Methadone Hydrochloride Solution; Oral SUPPL-46 West-Ward Pharms Int REMS Approved
Methadone Hydrochloride
ANDA #087997
Methadone Hydrochloride Solution; Oral SUPPL-38 West-Ward Pharms Int REMS Approved
Methadone Hydrochloride
ANDA #090065
Methadone Hydrochloride Tablet; Oral SUPPL-9 Epic Pharma Llc REMS Approved
Methadone Hydrochloride
ANDA #090635
Methadone Hydrochloride Tablet; Oral SUPPL-20 Thepharmanetwork Llc REMS Approved
Methadone Hydrochloride
ANDA #090707
Methadone Hydrochloride Solution; Oral SUPPL-17 Vistapharm REMS Approved
Methadone Hydrochloride
ANDA #203502
Methadone Hydrochloride Tablet; Oral SUPPL-5 Aurolife Pharma Llc REMS Approved
Methadone Hydrochloride
ANDA #208305
Methadone Hydrochloride Tablet; Oral SUPPL-2 Sun Pharm Industries REMS Approved
Methadone Hydrochloride
ANDA #210484
Methadone Hydrochloride Tablet; Oral SUPPL-1 Elite Labs Inc REMS Approved
Methadone Hydrochloride Intensol
ANDA #089897
Methadone Hydrochloride Concentrate; Oral SUPPL-39 West-Ward Pharms Int REMS Approved
Methadose
ANDA #040050
Methadone Hydrochloride Tablet; Oral SUPPL-27 Specgx Llc REMS Approved
Methadose
ANDA #074184
Methadone Hydrochloride Tablet, For Suspension; Oral SUPPL-22 Specgx Llc REMS Approved
Morphabond Er
NDA #206544
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-10 Daiichi Sankyo Inc Labeling Approved
Morphabond Er
NDA #206544
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-8 Daiichi Sankyo Inc REMS Approved
Morphine Sulfate
NDA #022195
Morphine Sulfate Solution; Oral SUPPL-16 West-Ward Pharms Int Labeling Approved
Morphine Sulfate
NDA #022195
Morphine Sulfate Solution; Oral SUPPL-14 West-Ward Pharms Int REMS Approved
Morphine Sulfate
NDA #022207
Morphine Sulfate Tablet; Oral SUPPL-8 West-Ward Pharms Int Labeling Approved
Morphine Sulfate
NDA #022207
Morphine Sulfate Tablet; Oral SUPPL-7 West-Ward Pharms Int REMS Approved
Morphine Sulfate
ANDA #074769
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-29 Rhodes Pharms REMS Approved
Morphine Sulfate
ANDA #074862
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-28 Rhodes Pharms REMS Approved
Morphine Sulfate
ANDA #075295
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-51 Vintage Pharms Llc REMS Approved
Morphine Sulfate
ANDA #076412
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-28 Specgx Llc REMS Approved
Morphine Sulfate
ANDA #076438
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-25 Specgx Llc REMS Approved
Morphine Sulfate
ANDA #076720
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-23 Nesher Pharms REMS Approved
Morphine Sulfate
ANDA #076733
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-22 Nesher Pharms REMS Approved
Morphine Sulfate
ANDA #077855
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-20 Nesher Pharms REMS Approved
Morphine Sulfate
ANDA #078761
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-13 Sun Pharm Inds Ltd REMS Approved
Morphine Sulfate
ANDA #079040
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-18 Actavis Elizabeth REMS Approved
Morphine Sulfate
ANDA #091357
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-4 Epic Pharma Llc REMS Approved
Morphine Sulfate
ANDA #200411
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-10 Impax Labs Inc REMS Approved
Morphine Sulfate
ANDA #200812
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-13 Par Pharm Inc REMS Approved
Morphine Sulfate
ANDA #200824
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-17 Mylan Pharms Inc REMS Approved
Morphine Sulfate
ANDA #201011
Morphine Sulfate Solution; Oral SUPPL-1 Nostrum Labs Inc REMS Approved
Morphine Sulfate
NDA #201517
Morphine Sulfate Solution; Oral SUPPL-13 Lannett Co Inc Labeling Approved
Morphine Sulfate
NDA #201517
Morphine Sulfate Solution; Oral SUPPL-12 Lannett Co Inc REMS Approved
Morphine Sulfate
ANDA #201574
Morphine Sulfate Solution; Oral SUPPL-3 Paddock Llc REMS Approved
Morphine Sulfate
ANDA #201947
Morphine Sulfate Solution; Oral SUPPL-4 Vistapharm REMS Approved
Morphine Sulfate
ANDA #202104
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-11 Upsher-Smith Labs REMS Approved
Morphine Sulfate
ANDA #202309
Morphine Sulfate Solution; Oral SUPPL-2 Lannett Co Inc REMS Approved
Morphine Sulfate
ANDA #202310
Morphine Sulfate Solution; Oral SUPPL-2 Lannett Co Inc REMS Approved
Morphine Sulfate
ANDA #202348
Morphine Sulfate Solution; Oral SUPPL-6 Specgx Llc REMS Approved
Morphine Sulfate
ANDA #202718
Morphine Sulfate Capsule, Extended Release; Oral SUPPL-7 Teva Pharms Usa REMS Approved
Morphine Sulfate
ANDA #203518
Morphine Sulfate Solution; Oral SUPPL-4 Tris Pharma Inc REMS Approved
Morphine Sulfate
ANDA #203519
Morphine Sulfate Solution; Oral SUPPL-2 Tris Pharma Inc REMS Approved
Morphine Sulfate
ANDA #203602
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-7 Novel Labs Inc REMS Approved
Morphine Sulfate
ANDA #203849
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-15 Actavis Elizabeth REMS Approved
Morphine Sulfate
ANDA #205386
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-5 Mayne Pharma Inc REMS Approved
Morphine Sulfate
ANDA #205509
Morphine Sulfate Solution; Oral SUPPL-1 Ani Pharms Inc REMS Approved
Morphine Sulfate
ANDA #205634
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-5 Sun Pharm Industries REMS Approved
Morphine Sulfate
ANDA #206308
Morphine Sulfate Solution; Oral SUPPL-1 Rhodes Pharms REMS Approved
Morphine Sulfate
ANDA #206420
Morphine Sulfate Solution; Oral SUPPL-1 Rhodes Pharms REMS Approved
Morphine Sulfate
ANDA #206573
Morphine Sulfate Solution; Oral SUPPL-1 Pharm Assoc REMS Approved
Morphine Sulfate
ANDA #208809
Morphine Sulfate Solution; Oral SUPPL-1 Hi-Tech Pharmacal REMS Approved
Ms Contin
NDA #019516
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-54 Purdue Pharma Lp Labeling Approved
Ms Contin
NDA #019516
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-54 Purdue Pharma Lp Labeling Approved
Ms Contin
NDA #019516
Morphine Sulfate Tablet, Extended Release; Oral SUPPL-53 Purdue Pharma Lp REMS Approved
Naloxone Hydrochloride and Pentazocine Hydrochloride
ANDA #074736
Naloxone Hydrochloride; Pentazocine Hydrochloride Tablet; Oral SUPPL-33 Watson Labs REMS Approved
Naloxone Hydrochloride and Pentazocine Hydrochloride
ANDA #075523
Naloxone Hydrochloride; Pentazocine Hydrochloride Tablet; Oral SUPPL-3 Sun Pharm Inds Ltd REMS Approved
Naloxone Hydrochloride and Pentazocine Hydrochloride
ANDA #075735
Naloxone Hydrochloride; Pentazocine Hydrochloride Tablet; Oral SUPPL-13 Gavis Pharms REMS Approved
Norco
ANDA #040099
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-21 Apil REMS Approved
Norco
ANDA #040148
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-71 Apil REMS Approved
Nucynta
NDA #022304
Tapentadol Hydrochloride Tablet; Oral SUPPL-21 Depomed Inc Labeling Approved
Nucynta
NDA #022304
Tapentadol Hydrochloride Tablet; Oral SUPPL-19 Depomed Inc REMS Approved
Nucynta
NDA #203794
Tapentadol Hydrochloride Solution; Oral SUPPL-6 Depomed Inc Labeling Approved
Nucynta
NDA #203794
Tapentadol Hydrochloride Solution; Oral SUPPL-5 Depomed Inc REMS Approved
Nucynta Er
NDA #200533
Tapentadol Hydrochloride Tablet, Extended Release; Oral SUPPL-19 Depomed Inc Labeling Approved
Nucynta Er
NDA #200533
Tapentadol Hydrochloride Tablet, Extended Release; Oral SUPPL-18 Depomed Inc REMS Approved
Opana
NDA #021611
Oxymorphone Hydrochloride Tablet; Oral SUPPL-15 Endo Pharms Labeling Approved
Opana
NDA #021611
Oxymorphone Hydrochloride Tablet; Oral SUPPL-13 Endo Pharms REMS Approved
Opana Er
NDA #021610
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-26 Endo Pharms Labeling Approved
Opana Er
NDA #021610
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-25 Endo Pharms REMS Approved
Opana Er
NDA #201655
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-25 Endo Pharms Labeling Approved
Opana Er
NDA #201655
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-24 Endo Pharms REMS Approved
Oxaydo
NDA #202080
Oxycodone Hydrochloride Tablet; Oral SUPPL-10 Egalet Us Inc Labeling Approved
Oxaydo
NDA #202080
Oxycodone Hydrochloride Tablet; Oral SUPPL-9 Egalet Us Inc REMS Approved
Oxycet
ANDA #087463
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-42 Specgx Llc REMS Approved
Oxycodone and Acetaminophen
ANDA #040105
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-31 Vintage Pharms REMS Approved
Oxycodone and Acetaminophen
ANDA #040171
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-33 Watson Labs REMS Approved
Oxycodone and Acetaminophen
ANDA #040203
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-9 Actavis Elizabeth REMS Approved
Oxycodone and Acetaminophen
ANDA #040535
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-33 Watson Labs REMS Approved
Oxycodone and Acetaminophen
ANDA #040545
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-15 Specgx Llc REMS Approved
Oxycodone and Acetaminophen
ANDA #040608
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-13 Mikart REMS Approved
Oxycodone and Acetaminophen
ANDA #040680
Acetaminophen; Oxycodone Hydrochloride Solution; Oral SUPPL-11 Specgx Llc REMS Approved
Oxycodone and Acetaminophen
ANDA #040777
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-14 Amneal Pharms REMS Approved
Oxycodone and Acetaminophen
ANDA #040778
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-16 Amneal Pharms Ny REMS Approved
Oxycodone and Acetaminophen
ANDA #040800
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-5 Actavis Elizabeth REMS Approved
Oxycodone and Acetaminophen
ANDA #090177
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-12 Mayne Pharma Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #090535
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-10 Sun Pharm Inds Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #090733
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-14 Vintage Pharms REMS Approved
Oxycodone and Acetaminophen
ANDA #090734
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-19 Vintage Pharms REMS Approved
Oxycodone and Acetaminophen
ANDA #201278
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-6 Rhodes Pharms REMS Approved
Oxycodone and Acetaminophen
ANDA #201447
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-14 Actavis Elizabeth REMS Approved
Oxycodone and Acetaminophen
ANDA #201972
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-11 Aurolife Pharma Llc REMS Approved
Oxycodone and Acetaminophen
ANDA #202677
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-10 Alvogen Malta REMS Approved
Oxycodone and Acetaminophen
ANDA #204407
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Novel Labs Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #207333
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-3 Lannett Co Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #207419
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Ascent Pharms Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #207510
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-1 Wes Pharma Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #207574
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-6 Chemo Research Sl REMS Approved
Oxycodone and Acetaminophen
ANDA #209385
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Elite Labs Inc REMS Approved
Oxycodone and Acetaminophen
ANDA #210079
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-1 Nesher Pharms REMS Approved
Oxycodone and Acetaminophen
ANDA #210644
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-1 Abhai Llc REMS Approved
Oxycodone and Aspirin
ANDA #040255
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-27 Watson Labs REMS Approved
Oxycodone and Aspirin
ANDA #040260
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-15 Sun Pharm Industries REMS Approved
Oxycodone and Aspirin
ANDA #087794
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-27 Sun Pharm Industries REMS Approved
Oxycodone and Aspirin
ANDA #090084
Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-5 Actavis Labs Fl Inc REMS Approved
Oxycodone and Aspirin
ANDA #091670
Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Mayne Pharma Inc REMS Approved
Oxycodone Hydrochloride
ANDA #076636
Oxycodone Hydrochloride Tablet; Oral SUPPL-35 Actavis Elizabeth REMS Approved
Oxycodone Hydrochloride
ANDA #076758
Oxycodone Hydrochloride Tablet; Oral SUPPL-17 Specgx Llc REMS Approved
Oxycodone Hydrochloride
ANDA #077290
Oxycodone Hydrochloride Tablet; Oral SUPPL-24 Nesher Pharms REMS Approved
Oxycodone Hydrochloride
ANDA #077712
Oxycodone Hydrochloride Tablet; Oral SUPPL-24 Vintage Pharms REMS Approved
Oxycodone Hydrochloride
ANDA #090659
Oxycodone Hydrochloride Tablet; Oral SUPPL-18 Sun Pharm Inds Inc REMS Approved
Oxycodone Hydrochloride
ANDA #090895
Oxycodone Hydrochloride Tablet; Oral SUPPL-10 Epic Pharma Llc REMS Approved
Oxycodone Hydrochloride
ANDA #091313
Oxycodone Hydrochloride Tablet; Oral SUPPL-6 Mayne Pharma Inc REMS Approved
Oxycodone Hydrochloride
ANDA #091393
Oxycodone Hydrochloride Tablet; Oral SUPPL-15 Avanthi Inc REMS Approved
Oxycodone Hydrochloride
ANDA #091490
Oxycodone Hydrochloride Tablet; Oral SUPPL-5 Rhodes Pharms REMS Approved
Oxycodone Hydrochloride
NDA #200534
Oxycodone Hydrochloride Capsule; Oral SUPPL-8 Genus Lifesciences Labeling Approved
Oxycodone Hydrochloride
NDA #200534
Oxycodone Hydrochloride Capsule; Oral SUPPL-7 Genus Lifesciences REMS Approved
Oxycodone Hydrochloride
NDA #200535
Oxycodone Hydrochloride Solution; Oral SUPPL-15 Genus Lifesciences Labeling Approved
Oxycodone Hydrochloride
NDA #200535
Oxycodone Hydrochloride Solution; Oral SUPPL-14 Genus Lifesciences REMS Approved
Oxycodone Hydrochloride
NDA #201194
Oxycodone Hydrochloride Solution; Oral SUPPL-4 Vistapharm Labeling Approved
Oxycodone Hydrochloride
NDA #201194
Oxycodone Hydrochloride Solution; Oral SUPPL-4 Vistapharm Labeling Approved
Oxycodone Hydrochloride
NDA #201194
Oxycodone Hydrochloride Solution; Oral SUPPL-3 Vistapharm REMS Approved
Oxycodone Hydrochloride
ANDA #202116
Oxycodone Hydrochloride Tablet; Oral SUPPL-5 Alvogen Malta REMS Approved
Oxycodone Hydrochloride
ANDA #202160
Oxycodone Hydrochloride Tablet; Oral SUPPL-4 Aurolife Pharma Llc REMS Approved
Oxycodone Hydrochloride
ANDA #202537
Oxycodone Hydrochloride Solution; Oral SUPPL-2 Vistapharm REMS Approved
Oxycodone Hydrochloride
ANDA #202662
Oxycodone Hydrochloride Tablet; Oral SUPPL-5 Epic Pharma Llc REMS Approved
Oxycodone Hydrochloride
ANDA #202773
Oxycodone Hydrochloride Capsule; Oral SUPPL-2 Avanthi Inc REMS Approved
Oxycodone Hydrochloride
ANDA #203107
Oxycodone Hydrochloride Capsule; Oral SUPPL-2 Mayne Pharma Inc REMS Approved
Oxycodone Hydrochloride
ANDA #203208
Oxycodone Hydrochloride Solution; Oral SUPPL-4 West-Ward Pharms Int REMS Approved
Oxycodone Hydrochloride
ANDA #203447
Oxycodone Hydrochloride Solution; Oral SUPPL-2 Ani Pharms Inc REMS Approved
Oxycodone Hydrochloride
ANDA #203638
Oxycodone Hydrochloride Tablet; Oral SUPPL-3 Amneal Pharms REMS Approved
Oxycodone Hydrochloride
ANDA #203823
Oxycodone Hydrochloride Capsule; Oral SUPPL-7 Lannett Co Inc REMS Approved
Oxycodone Hydrochloride
ANDA #204021
Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Novel Labs Inc REMS Approved
Oxycodone Hydrochloride
ANDA #204037
Oxycodone Hydrochloride Solution; Oral SUPPL-7 West-Ward Pharms Int REMS Approved
Oxycodone Hydrochloride
ANDA #204085
Oxycodone Hydrochloride Solution; Oral SUPPL-4 Lannett Co Inc REMS Approved
Oxycodone Hydrochloride
ANDA #204092
Oxycodone Hydrochloride Solution; Oral SUPPL-3 Mayne Pharma Inc REMS Approved
Oxycodone Hydrochloride
ANDA #204603
Oxycodone Hydrochloride Solution; Oral SUPPL-3 Novel Labs Inc REMS Approved
Oxycodone Hydrochloride
ANDA #204752
Oxycodone Hydrochloride Capsule; Oral SUPPL-1 Novel Labs Inc REMS Approved
Oxycodone Hydrochloride
ANDA #204979
Oxycodone Hydrochloride Solution; Oral SUPPL-4 Ani Pharms Inc REMS Approved
Oxycodone Hydrochloride
ANDA #205177
Oxycodone Hydrochloride Capsule; Oral SUPPL-4 Ani Pharms Inc REMS Approved
Oxycodone Hydrochloride
ANDA #206456
Oxycodone Hydrochloride Solution; Oral SUPPL-3 Wockhardt Bio Ag REMS Approved
Oxycodone Hydrochloride
ANDA #206822
Oxycodone Hydrochloride Solution; Oral SUPPL-1 Pharm Assoc REMS Approved
Oxycodone Hydrochloride
ANDA #207119
Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Ken Lifescience REMS Approved
Oxycodone Hydrochloride
ANDA #207418
Oxycodone Hydrochloride Tablet; Oral SUPPL-2 Ascent Pharms Inc REMS Approved
Oxycodone Hydrochloride
ANDA #207511
Oxycodone Hydrochloride Solution; Oral SUPPL-3 Wes Pharma Inc REMS Approved
Oxycodone Hydrochloride
ANDA #208593
Oxycodone Hydrochloride Solution; Oral SUPPL-1 Abhai Llc REMS Approved
Oxycodone Hydrochloride
ANDA #208795
Oxycodone Hydrochloride Solution; Oral SUPPL-1 Hi-Tech Pharmacal REMS Approved
Oxycodone Hydrochloride
ANDA #208817
Oxycodone Hydrochloride Solution; Oral SUPPL-1 Hi-Tech Pharmacal REMS Approved
Oxycodone Hydrochloride
ANDA #209021
Oxycodone Hydrochloride Solution; Oral SUPPL-2 Ascent Pharms Inc REMS Approved
Oxycodone Hydrochloride
ANDA #209897
Oxycodone Hydrochloride Solution; Oral SUPPL-1 Wes Pharma Inc REMS Approved
Oxycodone Hydrochloride and Acetaminophen
ANDA #203573
Acetaminophen; Oxycodone Hydrochloride Solution; Oral SUPPL-6 Vintage Pharms REMS Approved
Oxycodone Hydrochloride and Ibuprofen
ANDA #078316
Ibuprofen; Oxycodone Hydrochloride Tablet; Oral SUPPL-8 Barr Labs Inc REMS Approved
Oxycodone Hydrochloride and Ibuprofen
ANDA #078394
Ibuprofen; Oxycodone Hydrochloride Tablet; Oral SUPPL-15 Watson Labs REMS Approved
Oxycodone Hydrochloride and Ibuprofen
ANDA #078769
Ibuprofen; Oxycodone Hydrochloride Tablet; Oral SUPPL-22 Actavis Elizabeth REMS Approved
Oxycontin
NDA #022272
Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-41 Purdue Pharma Lp Labeling Approved
Oxycontin
NDA #022272
Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-40 Purdue Pharma Lp REMS Approved
Oxymorphone Hydrochloride
ANDA #079046
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-28 Actavis Elizabeth REMS Approved
Oxymorphone Hydrochloride
ANDA #079087
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-32 Impax Labs REMS Approved
Oxymorphone Hydrochloride
ANDA #090964
Oxymorphone Hydrochloride Tablet; Oral SUPPL-6 West-Ward Pharms Int REMS Approved
Oxymorphone Hydrochloride
ANDA #091443
Oxymorphone Hydrochloride Tablet; Oral SUPPL-9 Teva REMS Approved
Oxymorphone Hydrochloride
ANDA #200822
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-12 West-Ward Pharms Int REMS Approved
Oxymorphone Hydrochloride
ANDA #201187
Oxymorphone Hydrochloride Tablet; Oral SUPPL-4 Epic Pharma Llc REMS Approved
Oxymorphone Hydrochloride
ANDA #202321
Oxymorphone Hydrochloride Tablet; Oral SUPPL-3 Specgx Llc REMS Approved
Oxymorphone Hydrochloride
ANDA #202946
Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Specgx Llc REMS Approved
Oxymorphone Hydrochloride
ANDA #203601
Oxymorphone Hydrochloride Tablet; Oral SUPPL-5 Avanthi Inc REMS Approved
Oxymorphone Hydrochloride
ANDA #204459
Oxymorphone Hydrochloride Tablet; Oral SUPPL-2 Aurolife Pharma Llc REMS Approved
Oxymorphone Hydrochloride
ANDA #210175
Oxymorphone Hydrochloride Tablet; Oral SUPPL-2 Ascent Pharms Inc REMS Approved
Percocet
ANDA #040330
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-50 Vintage Pharms Llc REMS Approved
Percocet
ANDA #085106
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-27 Vintage Pharms Llc REMS Approved
Percodan
NDA #007337
Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-51 Endo Pharms Labeling Approved
Percodan
NDA #007337
Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-50 Endo Pharms REMS Approved
Percodan
NDA #007337
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-51 Endo Pharms Labeling Approved
Percodan
NDA #007337
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-50 Endo Pharms REMS Approved
Percodan-Demi
NDA #007337
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-51 Endo Pharms Labeling Approved
Percodan-Demi
NDA #007337
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-50 Endo Pharms REMS Approved
Reprexain
ANDA #076642
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-25 Amneal Pharms Ny REMS Approved
Roxicet
ANDA #087003
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-41 West-Ward Pharms Int REMS Approved
Roxicet
ANDA #089351
Acetaminophen; Oxycodone Hydrochloride Solution; Oral SUPPL-29 West-Ward Pharms Int REMS Approved
Roxicodone
NDA #021011
Oxycodone Hydrochloride Tablet; Oral SUPPL-9 Specgx Llc Labeling Approved
Roxicodone
NDA #021011
Oxycodone Hydrochloride Tablet; Oral SUPPL-8 Specgx Llc REMS Approved
Roxybond
NDA #209777
Oxycodone Hydrochloride Tablet; Oral SUPPL-3 Daiichi Sankyo Inc Labeling Approved
Roxybond
NDA #209777
Oxycodone Hydrochloride Tablet; Oral SUPPL-3 Daiichi Sankyo Inc Labeling Approved
Roxybond
NDA #209777
Oxycodone Hydrochloride Tablet; Oral SUPPL-1 Daiichi Sankyo Inc REMS Approved
Synalgos-Dc
NDA #011483
Aspirin; Caffeine; Dihydrocodeine Bitartrate Capsule; Oral SUPPL-32 Sun Pharm Industries Labeling Approved
Synalgos-Dc
NDA #011483
Aspirin; Caffeine; Dihydrocodeine Bitartrate Capsule; Oral SUPPL-31 Sun Pharm Industries REMS Approved
Targiniq
NDA #205777
Naloxone Hydrochloride; Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-11 Purdue Pharma Lp Labeling Approved
Targiniq
NDA #205777
Naloxone Hydrochloride; Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Purdue Pharma Lp REMS Approved
Tetracycline Hydrochloride
ANDA #210674
Tetracycline Hydrochloride Capsule; Oral ORIG-1 Amneal Pharms Ny Approved
Tramadol Hydrochloride
ANDA #075962
Tramadol Hydrochloride Tablet; Oral SUPPL-9 Watson Labs REMS Approved
Tramadol Hydrochloride
ANDA #075964
Tramadol Hydrochloride Tablet; Oral SUPPL-31 Sun Pharm Inds Inc REMS Approved
Tramadol Hydrochloride
ANDA #075968
Tramadol Hydrochloride Tablet; Oral SUPPL-11 Fosun Pharma REMS Approved
Tramadol Hydrochloride
ANDA #075977
Tramadol Hydrochloride Tablet; Oral SUPPL-17 Teva REMS Approved
Tramadol Hydrochloride
ANDA #075980
Tramadol Hydrochloride Tablet; Oral SUPPL-4 Mylan Pharms Inc REMS Approved
Tramadol Hydrochloride
ANDA #075981
Tramadol Hydrochloride Tablet; Oral SUPPL-18 Apotex REMS Approved
Tramadol Hydrochloride
ANDA #075982
Tramadol Hydrochloride Tablet; Oral SUPPL-14 Pliva REMS Approved
Tramadol Hydrochloride
ANDA #075983
Tramadol Hydrochloride Tablet; Oral SUPPL-12 Specgx Llc REMS Approved
Tramadol Hydrochloride
ANDA #075986
Tramadol Hydrochloride Tablet; Oral SUPPL-18 Mylan REMS Approved
Tramadol Hydrochloride
ANDA #076003
Tramadol Hydrochloride Tablet; Oral SUPPL-37 Amneal Pharms REMS Approved
Tramadol Hydrochloride
ANDA #076100
Tramadol Hydrochloride Tablet; Oral SUPPL-23 Sun Pharm Industries REMS Approved
Tramadol Hydrochloride
ANDA #078783
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Par Pharm Inc REMS Approved
Tramadol Hydrochloride
ANDA #090404
Tramadol Hydrochloride Tablet; Oral SUPPL-8 Zydus Pharms Usa Inc REMS Approved
Tramadol Hydrochloride
ANDA #091498
Tramadol Hydrochloride Tablet; Oral SUPPL-7 Cspc Ouyi Pharm Co REMS Approved
Tramadol Hydrochloride
ANDA #091607
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-14 Sun Pharma Global REMS Approved
Tramadol Hydrochloride
ANDA #091609
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-7 Actavis Elizabeth REMS Approved
Tramadol Hydrochloride
ANDA #200491
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Anchen Pharms REMS Approved
Tramadol Hydrochloride
ANDA #200503
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-7 Lupin Ltd REMS Approved
Tramadol Hydrochloride
ANDA #201384
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-12 Sun Pharma Global REMS Approved
Tramadol Hydrochloride
ANDA #201973
Tramadol Hydrochloride Tablet; Oral SUPPL-3 Ipca Labs Ltd REMS Approved
Tramadol Hydrochloride
ANDA #203494
Tramadol Hydrochloride Tablet; Oral SUPPL-8 Aurobindo Pharma Ltd REMS Approved
Tramadol Hydrochloride
ANDA #204421
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-6 Aurobindo Pharma Ltd REMS Approved
Tramadol Hydrochloride
ANDA #205257
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-6 Mylan Pharms Inc REMS Approved
Tramadol Hydrochloride
ANDA #205702
Tramadol Hydrochloride Tablet; Oral SUPPL-7 Macleods Pharms Ltd REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #076475
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-19 Par Pharm REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #076914
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-6 Cspc Ouyi Pharm Co REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #077184
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-15 Sun Pharm Inds Inc REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #077858
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-7 Mylan REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #078778
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-7 Apotex Inc REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #090460
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-9 Zydus Pharms Usa Inc REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #090485
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-16 Amneal Pharms REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #201952
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-9 Micro Labs Ltd India REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #202076
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-3 Alkem Labs Ltd REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #206885
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-10 Macleods Pharms Ltd REMS Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #207152
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-4 Aurobindo Pharma Ltd REMS Approved
Tylenol W/ Codeine No. 1
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-60 Janssen Pharms REMS Approved
Tylenol W/ Codeine No. 2
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-60 Janssen Pharms REMS Approved
Tylenol W/ Codeine No. 3
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-60 Janssen Pharms REMS Approved
Tylenol W/ Codeine No. 4
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-60 Janssen Pharms REMS Approved
Ultracet
NDA #021123
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-17 Janssen Pharms Labeling Approved
Ultracet
NDA #021123
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-16 Janssen Pharms REMS Approved
Ultram
NDA #020281
Tramadol Hydrochloride Tablet; Oral SUPPL-43 Janssen Pharms Labeling Approved
Ultram
NDA #020281
Tramadol Hydrochloride Tablet; Oral SUPPL-42 Janssen Pharms REMS Approved
Xartemis Xr
NDA #204031
Acetaminophen; Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Mallinckrodt Inc Labeling Approved
Xartemis Xr
NDA #204031
Acetaminophen; Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-4 Mallinckrodt Inc REMS Approved
Xtampza Er
NDA #208090
Oxycodone Capsule, Extended Release; Oral SUPPL-10 Collegium Pharm Inc Labeling Approved
Xtampza Er
NDA #208090
Oxycodone Capsule, Extended Release; Oral SUPPL-8 Collegium Pharm Inc REMS Approved
Zohydro Er
NDA #202880
Hydrocodone Bitartrate Capsule, Extended Release; Oral SUPPL-15 Pernix Ireland Pain Labeling Approved
Zohydro Er
NDA #202880
Hydrocodone Bitartrate Capsule, Extended Release; Oral SUPPL-14 Pernix Ireland Pain REMS Approved

September 17, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ritonavir
ANDA #204587
Ritonavir Tablet; Oral ORIG-1 Hetero Labs Ltd Iii Approved
Ritonavir
ANDA #206614
Ritonavir Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Ritonavir
ANDA #208890
Ritonavir Tablet; Oral ORIG-1 Amneal Pharms Llc Approved

September 14, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ajovy
BLA #761089
Fremanezumab-Vfrm Injectable; Injection ORIG-1 Teva Pharms Usa Type 1 - New Molecular Entity Approved
Ambien
NDA #019908
Zolpidem Tartrate Tablet; Oral SUPPL-42 Sanofi Aventis Us Labeling Approved
Ambien Cr
NDA #021774
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-23 Sanofi Aventis Us Labeling Approved
Clofarabine
ANDA #210270
Clofarabine Solution; Intravenous ORIG-1 Ingenus Pharms Llc Approved
Eplerenone
ANDA #208283
Eplerenone Tablet; Oral ORIG-1 Breckenridge Pharm Approved
Estradiol
ANDA #210264
Estradiol Tablet; Vaginal ORIG-1 Glenmark Pharms Ltd Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077723
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-19 Vintage Pharms Labeling Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077723
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-19 Vintage Pharms Labeling Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077727
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-15 Vintage Pharms Labeling Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #077727
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-15 Vintage Pharms Labeling Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #091633
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-8 Sun Pharm Inds Inc Labeling Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #091633
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-3 Sun Pharm Inds Inc Labeling Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #091633
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-8 Sun Pharm Inds Inc Labeling Approved
Ingenol Mebutate
ANDA #209019
Ingenol Mebutate Gel; Topical ORIG-1 Perrigo Uk Finco Tentative Approval
Levoleucovorin Calcium
ANDA #210892
Levoleucovorin Calcium Solution; Intravenous ORIG-1 Gland Pharma Ltd Approved
Magnesium Sulfate In Plastic Container
ANDA #209911
Magnesium Sulfate Injectable; Injection ORIG-1 Mylan Labs Ltd Approved
Novothyrox
NDA #021292
Levothyroxine Sodium Tablet; Oral SUPPL-4 Merck Kgaa Efficacy Approved
Novothyrox
NDA #021292
Levothyroxine Sodium Tablet; Oral SUPPL-5 Merck Kgaa Labeling Approved
Novothyrox
NDA #021292
Levothyroxine Sodium Tablet; Oral SUPPL-6 Merck Kgaa Labeling Approved
Seizalam
NDA #209566
Midazolam Injectable; Injection ORIG-1 Meridian Medcl Techn Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approved
Silodosin
ANDA #211060
Silodosin Unknown ORIG-1 Ajanta Pharma Ltd Tentative Approval
Sodium Chloride 3% In Plastic Container
NDA #019022
Sodium Chloride Injectable; Injection SUPPL-31 Baxter Hlthcare Labeling Approved
Sodium Chloride 5% In Plastic Container
NDA #019022
Sodium Chloride Injectable; Injection SUPPL-31 Baxter Hlthcare Labeling Approved
Solifenacin Succinate
ANDA #210688
Solifenacin Succinate Unknown ORIG-1 Msn Labs Pvt Ltd Tentative Approval
Syndros
NDA #205525
Dronabinol Solution; Oral SUPPL-7 Insys Dev Co Inc Labeling Approved

September 13, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Hydrocodone Bitartrate and Acetaminophen
ANDA #207709
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral ORIG-1 Aurolife Pharma Llc Approved
Lansoprazole
ANDA #200816
Lansoprazole Unknown ORIG-1 Zydus Pharms Usa Inc Tentative Approval
Lumoxiti
BLA #761104
Moxetumomab Pasudotox-Tdfk Injectable; Injection ORIG-1 Astrazeneca Ab Type 1 - New Molecular Entity Approved

September 12, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Actemra
BLA #125276
Tocilizumab Injectable; Injection SUPPL-122 Genentech Labeling Approved
Actemra
BLA #125472
Tocilizumab Injectable; Intravenous, Subcutaneous SUPPL-31 Genentech Efficacy Approved
Botox
BLA #103000
Onabotulinumtoxina Vial; Single-Use SUPPL-5308 Allergan Efficacy Approved
Botox Cosmetic
BLA #103000
Onabotulinumtoxina Vial; Single-Use SUPPL-5308 Allergan Efficacy Approved
Caduet
NDA #021540
Amlodipine Besylate; Atorvastatin Calcium Tablet; Oral SUPPL-42 Pfizer Labeling Approved
Caduet
NDA #021540
Amlodipine Besylate; Atorvastatin Calcium Tablet; Oral SUPPL-43 Pfizer Labeling Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #202214
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Tris Pharma Inc Labeling Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #202214
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Tris Pharma Inc Labeling Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #202214
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-7 Tris Pharma Inc Labeling Approved
Invanz
NDA #021337
Ertapenem Sodium Injectable; Intramuscular, Iv (Infusion) SUPPL-46 Merck Sharp Dohme Labeling Approved
Spritam
NDA #207958
Levetiracetam Tablet, For Suspension; Oral SUPPL-8 Aprecia Pharms Labeling Approved
Spritam
NDA #207958
Levetiracetam Tablet, For Suspension; Oral SUPPL-8 Aprecia Pharms Labeling Approved
Tranexamic Acid
ANDA #202755
Tranexamic Acid Injectable; Injection SUPPL-1 Virtus Pharms Manufacturing (CMC) Approved
Xelpros
NDA #206185
Latanoprost Emulsion; Ophthalmic ORIG-1 Sun Pharma Global Type 3 - New Dosage Form Approved

September 11, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atovaquone
ANDA #209105
Atovaquone Suspension; Oral ORIG-1 Lupin Ltd Approved
Carmustine
ANDA #210179
Carmustine Injectable; Injection ORIG-1 Navinta Llc Approved
Dimethyl Fumarate
ANDA #210440
Dimethyl Fumarate Unknown ORIG-1 Alkem Labs Ltd Tentative Approval
Hydrocodone Bitartrate and Acetaminophen
ANDA #206142
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-3 Novel Labs Inc Labeling Approved
Oxycodone and Aspirin
ANDA #090084
Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-6 Actavis Labs Fl Inc Labeling Approved
Oxycodone and Aspirin
ANDA #090084
Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-6 Actavis Labs Fl Inc Labeling Approved
Risedronate Sodium
ANDA #203822
Risedronate Sodium Tablet, Delayed Release; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Tramadol Hydrochloride
ANDA #204421
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Aurobindo Pharma Ltd Labeling Approved
Tramadol Hydrochloride
ANDA #204421
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Aurobindo Pharma Ltd Labeling Approved

September 10, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Chlorpromazine Hydrochloride
ANDA #209755
Chlorpromazine Hydrochloride Tablet; Oral ORIG-1 Amneal Pharms Co Approved
Drospirenone and Ethinyl Estradiol
ANDA #210017
Drospirenone; Ethinyl Estradiol Tablet; Oral-28 ORIG-1 Cyndea Pharma Approved
Fenofibrate (Micronized)
ANDA #210705
Fenofibrate Capsule; Oral ORIG-1 Ajanta Pharma Ltd Approved
Ibuprofen
ANDA #204062
Ibuprofen Tablet; Oral ORIG-1 Hec Pharm Approved
Magnesium Sulfate In Dextrose 5% In Plastic Container
ANDA #209932
Magnesium Sulfate Injectable; Injection ORIG-1 Mylan Labs Ltd Approved
Metformin Hydrochloride
ANDA #208880
Metformin Hydrochloride Tablet, Extended Release; Oral ORIG-1 Prinston Inc Approved
Methylergonovine Maleate
ANDA #211483
Methylergonovine Maleate Tablet; Oral ORIG-1 Amneal Pharms Approved
Retrovir
NDA #019655
Zidovudine Capsule; Oral SUPPL-58 Viiv Hlthcare Labeling Approved
Retrovir
NDA #019655
Zidovudine Capsule; Oral SUPPL-58 Viiv Hlthcare Labeling Approved
Retrovir
NDA #019910
Zidovudine Syrup; Oral SUPPL-45 Viiv Hlthcare Labeling Approved
Retrovir
NDA #019910
Zidovudine Syrup; Oral SUPPL-45 Viiv Hlthcare Labeling Approved
Retrovir
NDA #019951
Zidovudine Injectable; Injection SUPPL-36 Viiv Hlthcare Labeling Approved
Retrovir
NDA #019951
Zidovudine Injectable; Injection SUPPL-36 Viiv Hlthcare Labeling Approved

September 7, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cassipa
NDA #208042
Buprenorphine;Naloxone Film; Buccal, Sublingual ORIG-1 Teva Pharms Usa Inc Type 5 - New Formulation or New Manufacturer Approved
Copaxone
NDA #020622
Glatiramer Acetate For Solution; Subcutaneous SUPPL-104 Teva Pharms Usa Labeling Approved
Copaxone
NDA #020622
Glatiramer Acetate For Solution; Subcutaneous SUPPL-104 Teva Pharms Usa Labeling Approved
Copaxone
NDA #020622
Glatiramer Acetate Injectable; Subcutaneous SUPPL-104 Teva Pharms Usa Labeling Approved
Copaxone
NDA #020622
Glatiramer Acetate Injectable; Subcutaneous SUPPL-104 Teva Pharms Usa Labeling Approved
Lurasidone Hydrochrloride
ANDA #208055
Lurasidone Hydrochrloride Tablet; Oral ORIG-1 Torrent Pharms Ltd Tentative Approval
Octreotide Acetate
ANDA #203765
Octreotide Acetate Injectable; Injection ORIG-1 Usv North America Approved
Prezcobix
NDA #205395
Cobicistat; Darunavir Ethanolate Tablet; Oral SUPPL-10 Janssen Prods Labeling Approved
Prezcobix
NDA #205395
Cobicistat; Darunavir Ethanolate Tablet; Oral SUPPL-10 Janssen Prods Labeling Approved
Prezista
NDA #021976
Darunavir Ethanolate Tablet; Oral SUPPL-51 Janssen Prods Labeling Approved
Prezista
NDA #021976
Darunavir Ethanolate Tablet; Oral SUPPL-51 Janssen Prods Labeling Approved
Prezista
NDA #202895
Darunavir Ethanolate Suspension; Oral SUPPL-22 Janssen Prods Labeling Approved
Prezista
NDA #202895
Darunavir Ethanolate Suspension; Oral SUPPL-22 Janssen Prods Labeling Approved
Sitagliptin
ANDA #208186
Sitagliptin Unknown ORIG-1 Zydus Pharms Usa Inc Tentative Approval
Venclexta
NDA #208573
Venetoclax Tablet; Oral SUPPL-7 Abbvie Inc Efficacy Approved
Venclexta
NDA #208573
Venetoclax Tablet; Oral SUPPL-10 Abbvie Inc Labeling Approved

September 6, 2018

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Astelin
NDA #020114
Azelastine Hydrochloride Spray, Metered; Nasal SUPPL-28 Mylan Speciality Lp Labeling Approved
Astepro
NDA #022203
Azelastine Hydrochloride Spray, Metered; Nasal SUPPL-15 Mylan Speciality Lp Labeling Approved
Dymista
NDA #202236
Azelastine Hydrochloride; Fluticasone Propionate Spray, Metered; Nasal SUPPL-10 Mylan Speciality Lp Labeling Approved
Juluca
NDA #210192
Dolutegravir Sodium; Rilpivirine Hydrochloride Tablet; Oral SUPPL-2 Viiv Hlthcare Labeling Approved
Juluca
NDA #210192
Dolutegravir Sodium; Rilpivirine Hydrochloride Tablet; Oral SUPPL-4 Viiv Hlthcare Labeling Approved
Oxybutynin Chloride
ANDA #210125
Oxybutynin Chloride Tablet; Oral ORIG-1 Tulex Pharms Inc Approved
Tivicay
NDA #204790
Dolutegravir Sodium Tablet; Oral SUPPL-16 Viiv Hlthcare Labeling Approved
Tivicay
NDA #204790
Dolutegravir Sodium Tablet; Oral SUPPL-18 Viiv Hlthcare Labeling Approved
Triumeq
NDA #205551
Abacavir Sulfate; Dolutegravir Sodium; Lamivudine Tablet; Oral SUPPL-14 Viiv Hlthcare Labeling Approved
Triumeq
NDA #205551
Abacavir Sulfate; Dolutegravir Sodium; Lamivudine Tablet; Oral SUPPL-15 Viiv Hlthcare Labeling Approved

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