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.

7 Day Report
14 Day Report

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 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 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