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.

June 23, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bevyxxa
NDA #208383
Betrixaban Capsule; Oral ORIG-1 Portola Pharma Inc Type 1 - New Molecular Entity Approved

June 22, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amantadine Hydrochloride
ANDA #208107
Amantadine Hydrochloride Capsule; Oral SUPPL-2 Watson Labs Inc Manufacturing (CMC) Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207172
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral ORIG-1 Lannett Holdings Inc Approved
Mekinist
NDA #204114
Trametinib Dimethyl Sulfoxide Tablet; Oral SUPPL-5 Novartis Pharms Corp Efficacy Approved
Primaquine
NDA #008316
Primaquine Phosphate Tablet; Oral SUPPL-23 Sanofi Aventis Us Labeling Approved
Rituxan Hycela
BLA #761064
Hyaluronidase;Rituximab Injectable; Injection ORIG-1 Genentech Inc Type 5 - New Formulation or New Manufacturer Approved
Rituxan Hycela
BLA #761064
Hyaluronidase;Rituximab Injectable; Injection SUPPL-1 Genentech Inc Type 5 - New Formulation or New Manufacturer Approved
Simponi
BLA #125289
Golimumab Injectable; Injection SUPPL-133 Centocor Ortho Biotech Inc Efficacy Approved
Tafinlar
NDA #202806
Dabrafenib Mesylate Capsule; Oral SUPPL-6 Novartis Pharms Corp Efficacy Approved

June 21, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amantadine Hydrochloride
ANDA #208966
Amantadine Hydrochloride Capsule; Oral ORIG-1 Alembic Pharms Ltd Approved
Children's Advil
NDA #020589
Ibuprofen Suspension; Oral SUPPL-35 Pfizer Labeling Approved
Children's Advil-Flavored
NDA #020589
Ibuprofen Suspension; Oral SUPPL-35 Pfizer Labeling Approved
Daraprim
NDA #008578
Pyrimethamine Tablet; Oral SUPPL-20 Turing Pharms Llc Labeling Approved
Estrace
ANDA #086069
Estradiol Cream; Vaginal SUPPL-23 Allergan Sales Llc Labeling Approved
Granix
BLA #125294
Tbo-Filgrastim Injectable; Injection SUPPL-42 Sicor Biotech Labeling Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #209036
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral ORIG-1 Abhai Llc Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #209037
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral ORIG-1 Abhai Llc Approved
Imatinib Mesylate
ANDA #204644
Imatinib Mesylate Tablet; Oral ORIG-1 Mylan Pharms Inc Approved
Synribo
NDA #203585
Omacetaxine Mepesuccinate Powder; Subcutaneous SUPPL-5 Teva Pharms Intl Labeling Approved

June 20, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide Sodium
ANDA #205358
Acetazolamide Sodium Injectable; Injection ORIG-1 Par Sterile Products Approved
Candesartan Cilexetil
ANDA #209119
Candesartan Cilexetil Tablet; Oral ORIG-1 Alembic Pharms Ltd Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207171
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral ORIG-1 Lannett Holdings Inc Approved
Lidocaine
ANDA #206297
Lidocaine Ointment; Topical SUPPL-3 Amneal Pharms Manufacturing (CMC) Approved
Metronidazole
ANDA #208681
Metronidazole Tablet; Oral ORIG-1 Orit Labs Llc Approved
Mydayis
NDA #022063
Mixed Salts Of A Single-Entity Amphetamine Capsule, Extended Release; Oral ORIG-1 Shire Dev Llc Type 3 - New Dosage Form Approved
Paroxetine Mesylate
ANDA #207139
Paroxetine Mesylate Capsule; Oral ORIG-1 Actavis Labs Fl Inc Approved
Piroxicam
ANDA #206136
Piroxicam Capsule; Oral ORIG-1 Pii Approved
Solifenacin Succinate
ANDA #209239
Solifenacin Succinate Tablet; Oral ORIG-1 Glenmark Pharms Tentative Approval

June 19, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azithromycin
ANDA #207566
Azithromycin Tablet; Oral ORIG-1 Cspc Ouyi Pharmaceutical Co. Ltd. Tentative Approval
Baxdela
NDA #208610
Delafloxacin Tablet; Oral ORIG-1 Melinta Therapeutics Inc Type 1 - New Molecular Entity Approved
Baxdela
NDA #208611
Delafloxacin Injectable; Injection ORIG-1 Melinta Therapeutics Inc Type 1 - New Molecular Entity Approved
Cotempla Xr-Odt
NDA #205489
Methylphenidate Tablet, Orally Disintegrating, Extended Release; Oral ORIG-1 Neos Therap Inc Type 3 - New Dosage Form Approved
Dantrolene Sodium
ANDA #204762
Dantrolene Sodium Injectable; Injection ORIG-1 Hikma Pharms Llc Approved
Prezista
NDA #021976
Darunavir Ethanolate Tablet; Oral SUPPL-45 Janssen Prods Labeling Approved
Prezista
NDA #021976
Darunavir Ethanolate Tablet; Oral SUPPL-45 Janssen Prods Labeling Approved
Prezista
NDA #202895
Darunavir Ethanolate Suspension; Oral SUPPL-20 Janssen Prods Labeling Approved
Prezista
NDA #202895
Darunavir Ethanolate Suspension; Oral SUPPL-20 Janssen Prods Labeling Approved
Taclonex
NDA #022185
Betamethasone Dipropionate; Calcipotriene Hydrate Suspension; Topical SUPPL-25 Leo Pharma As Manufacturing (CMC) Approved

June 17, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Absorica
NDA #021951
Isotretinoin Capsule; Oral SUPPL-10 Ranbaxy REMS Approved
Amnesteem
ANDA #075945
Isotretinoin Capsule; Oral SUPPL-34 Mylan Pharms Inc REMS Approved
Claravis
ANDA #076135
Isotretinoin Capsule; Oral SUPPL-38 Teva Pharms Usa REMS Approved
Claravis
ANDA #076356
Isotretinoin Capsule; Oral SUPPL-35 Teva Pharms Usa REMS Approved
Myorisan
ANDA #076485
Isotretinoin Capsule; Oral SUPPL-15 Douglas Pharms REMS Approved
Zenatane
ANDA #202099
Isotretinoin Capsule; Oral SUPPL-9 Dr Reddys Labs Ltd REMS Approved

June 16, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Addyi
NDA #022526
Flibanserin Tablet; Oral SUPPL-4 Sprout Pharms REMS Approved
Aurovela 1/20
ANDA #207506
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-21 ORIG-1 Aurobindo Pharma Ltd Approved
Aurovela Fe 1/20
ANDA #207505
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-28 ORIG-1 Aurobindo Pharma Ltd Approved
Cisatracurium Besylate
ANDA #205873
Cisatracurium Besylate Injectable; Injection ORIG-1 Accord Hlthcare Approved
Cisatracurium Besylate Preservative Free
ANDA #205872
Cisatracurium Besylate Injectable; Injection ORIG-1 Accord Hlthcare Approved
Darzalex
BLA #761036
Daratumumab Injectable; Injection SUPPL-5 Janssen Biotech Efficacy Approved
Diflunisal
ANDA #203547
Diflunisal Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Eletriptan Hydrobromide
ANDA #206409
Eletriptan Hydrobromide Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Felbamate
ANDA #206314
Felbamate Suspension; Oral ORIG-1 Taro Pharm Approved
Her Style
ANDA #207976
Levonorgestrel Tablet; Oral SUPPL-1 Novast Labs Ltd Labeling Approved
Her Style
ANDA #207976
Levonorgestrel Tablet; Oral SUPPL-2 Novast Labs Ltd Labeling Approved
Her Style
ANDA #207976
Levonorgestrel Tablet; Oral SUPPL-1 Novast Labs Ltd Labeling Approved
Her Style
ANDA #207976
Levonorgestrel Tablet; Oral SUPPL-2 Novast Labs Ltd Labeling Approved
Lamotrigine
ANDA #078947
Lamotrigine Tablet; Oral SUPPL-22 Torrent Pharms Labeling Approved
Lamotrigine
ANDA #078947
Lamotrigine Tablet; Oral SUPPL-23 Torrent Pharms Labeling Approved
Linagliptin
ANDA #208415
Linagliptin Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Tentative Approval
Neuraceq
NDA #204677
Florbetaben F-18 Solution; Intravenous SUPPL-14 Piramal Imaging Labeling Approved
Niacin
ANDA #203899
Niacin Tablet, Extended Release; Oral ORIG-1 Lannett Approved
Olanzapine
ANDA #204866
Olanzapine Tablet; Oral ORIG-1 Hikma Pharms Llc Approved
Oxycodone and Acetaminophen
ANDA #201972
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-7 Aurolife Pharma Llc Labeling Approved
Oxycodone and Acetaminophen
ANDA #201972
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-7 Aurolife Pharma Llc Labeling Approved
Propranolol Hydrochloride
ANDA #070690
Propranolol Hydrochloride Solution; Oral SUPPL-21 West-Ward Pharms Int Labeling Approved
Sklice
NDA #202736
Ivermectin Lotion; Topical SUPPL-3 Arbor Pharms Llc Labeling Approved
Synercid
NDA #050747
Quinupristin; Dalfopristin Injectable; Injection SUPPL-15 King Pharms Labeling Approved
Synercid
NDA #050748
Dalfopristin; Quinupristin Injectable; Iv (Infusion) SUPPL-14 King Pharms Labeling Approved
Tafinlar
NDA #202806
Dabrafenib Mesylate Capsule; Oral SUPPL-7 Novartis Pharms Corp Labeling Approved
Testosterone Cypionate
ANDA #207742
Testosterone Cypionate Injectable; Injection ORIG-1 Luitpold Pharms Inc Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #076914
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-4 Watson Labs Labeling Approved
Xadago
NDA #207145
Safinamide Mesylate Tablet; Oral SUPPL-1 Us Worldmeds Llc Labeling Approved

June 15, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amantadine Hydrochloride
ANDA #209221
Amantadine Hydrochloride Capsule; Oral ORIG-1 Lannett Holdings Inc Approved
Aurovela 24 Fe
ANDA #207504
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Aurovela Fe 1.5/30
ANDA #207580
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-28 ORIG-1 Aurobindo Pharma Ltd Approved
Calcium Gluconate
NDA #208418
Calcium Gluconate Injectable; Injection ORIG-1 Fresenius Kabi Usa Type 7 - Drug Already Marketed without Approved NDA Approved
Glycopyrrolate
ANDA #208973
Glycopyrrolate Injectable; Injection ORIG-1 Amneal Pharms Co Approved
Invega Sustenna
NDA #022264
Paliperidone Palmitate Suspension, Extended Release; Intramuscular SUPPL-23 Janssen Pharms Labeling Approved
Kaletra
NDA #021226
Lopinavir; Ritonavir Capsule; Oral SUPPL-45 Abbvie Labeling Approved
Kaletra
NDA #021226
Lopinavir; Ritonavir Capsule; Oral SUPPL-45 Abbvie Labeling Approved
Kaletra
NDA #021251
Lopinavir; Ritonavir Solution; Oral SUPPL-54 Abbvie Labeling Approved
Kaletra
NDA #021251
Lopinavir; Ritonavir Solution; Oral SUPPL-54 Abbvie Labeling Approved
Kaletra
NDA #021906
Lopinavir; Ritonavir Tablet; Oral SUPPL-49 Abbvie Labeling Approved
Kaletra
NDA #021906
Lopinavir; Ritonavir Tablet; Oral SUPPL-49 Abbvie Labeling Approved
Metaxalone
ANDA #203695
Metaxalone Tablet; Oral ORIG-1 Actavis Labs Fl Inc Approved
Symjepi
NDA #207534
Epinephrine Injectable; Injection ORIG-1 Adamis Pharmaceuticals Corp Type 5 - New Formulation or New Manufacturer Approved
Vfend
NDA #021266
Voriconazole Tablet; Oral SUPPL-41 Pf Prism Cv Labeling Approved
Vfend
NDA #021267
Voriconazole Injectable; Iv (Infusion) SUPPL-53 Pf Prism Cv Labeling Approved
Vfend
NDA #021630
Voriconazole For Suspension; Oral SUPPL-31 Pf Prism Cv Labeling Approved
Zoloft
NDA #019839
Sertraline Hydrochloride Tablet; Oral SUPPL-88 Pfizer Labeling Approved
Zoloft
NDA #020990
Sertraline Hydrochloride Concentrate; Oral SUPPL-46 Pfizer Labeling Approved

June 23, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bevyxxa
NDA #208383
Betrixaban Capsule; Oral ORIG-1 Portola Pharma Inc Type 1 - New Molecular Entity Approved

June 22, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amantadine Hydrochloride
ANDA #208107
Amantadine Hydrochloride Capsule; Oral SUPPL-2 Watson Labs Inc Manufacturing (CMC) Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207172
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral ORIG-1 Lannett Holdings Inc Approved
Mekinist
NDA #204114
Trametinib Dimethyl Sulfoxide Tablet; Oral SUPPL-5 Novartis Pharms Corp Efficacy Approved
Primaquine
NDA #008316
Primaquine Phosphate Tablet; Oral SUPPL-23 Sanofi Aventis Us Labeling Approved
Rituxan Hycela
BLA #761064
Hyaluronidase;Rituximab Injectable; Injection ORIG-1 Genentech Inc Type 5 - New Formulation or New Manufacturer Approved
Rituxan Hycela
BLA #761064
Hyaluronidase;Rituximab Injectable; Injection SUPPL-1 Genentech Inc Type 5 - New Formulation or New Manufacturer Approved
Simponi
BLA #125289
Golimumab Injectable; Injection SUPPL-133 Centocor Ortho Biotech Inc Efficacy Approved
Tafinlar
NDA #202806
Dabrafenib Mesylate Capsule; Oral SUPPL-6 Novartis Pharms Corp Efficacy Approved

June 21, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amantadine Hydrochloride
ANDA #208966
Amantadine Hydrochloride Capsule; Oral ORIG-1 Alembic Pharms Ltd Approved
Children's Advil
NDA #020589
Ibuprofen Suspension; Oral SUPPL-35 Pfizer Labeling Approved
Children's Advil-Flavored
NDA #020589
Ibuprofen Suspension; Oral SUPPL-35 Pfizer Labeling Approved
Daraprim
NDA #008578
Pyrimethamine Tablet; Oral SUPPL-20 Turing Pharms Llc Labeling Approved
Estrace
ANDA #086069
Estradiol Cream; Vaginal SUPPL-23 Allergan Sales Llc Labeling Approved
Granix
BLA #125294
Tbo-Filgrastim Injectable; Injection SUPPL-42 Sicor Biotech Labeling Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #209036
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral ORIG-1 Abhai Llc Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #209037
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral ORIG-1 Abhai Llc Approved
Imatinib Mesylate
ANDA #204644
Imatinib Mesylate Tablet; Oral ORIG-1 Mylan Pharms Inc Approved
Synribo
NDA #203585
Omacetaxine Mepesuccinate Powder; Subcutaneous SUPPL-5 Teva Pharms Intl Labeling Approved

June 20, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide Sodium
ANDA #205358
Acetazolamide Sodium Injectable; Injection ORIG-1 Par Sterile Products Approved
Candesartan Cilexetil
ANDA #209119
Candesartan Cilexetil Tablet; Oral ORIG-1 Alembic Pharms Ltd Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #207171
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral ORIG-1 Lannett Holdings Inc Approved
Lidocaine
ANDA #206297
Lidocaine Ointment; Topical SUPPL-3 Amneal Pharms Manufacturing (CMC) Approved
Metronidazole
ANDA #208681
Metronidazole Tablet; Oral ORIG-1 Orit Labs Llc Approved
Mydayis
NDA #022063
Mixed Salts Of A Single-Entity Amphetamine Capsule, Extended Release; Oral ORIG-1 Shire Dev Llc Type 3 - New Dosage Form Approved
Paroxetine Mesylate
ANDA #207139
Paroxetine Mesylate Capsule; Oral ORIG-1 Actavis Labs Fl Inc Approved
Piroxicam
ANDA #206136
Piroxicam Capsule; Oral ORIG-1 Pii Approved
Solifenacin Succinate
ANDA #209239
Solifenacin Succinate Tablet; Oral ORIG-1 Glenmark Pharms Tentative Approval

June 19, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azithromycin
ANDA #207566
Azithromycin Tablet; Oral ORIG-1 Cspc Ouyi Pharmaceutical Co. Ltd. Tentative Approval
Baxdela
NDA #208610
Delafloxacin Tablet; Oral ORIG-1 Melinta Therapeutics Inc Type 1 - New Molecular Entity Approved
Baxdela
NDA #208611
Delafloxacin Injectable; Injection ORIG-1 Melinta Therapeutics Inc Type 1 - New Molecular Entity Approved
Cotempla Xr-Odt
NDA #205489
Methylphenidate Tablet, Orally Disintegrating, Extended Release; Oral ORIG-1 Neos Therap Inc Type 3 - New Dosage Form Approved
Dantrolene Sodium
ANDA #204762
Dantrolene Sodium Injectable; Injection ORIG-1 Hikma Pharms Llc Approved
Prezista
NDA #021976
Darunavir Ethanolate Tablet; Oral SUPPL-45 Janssen Prods Labeling Approved
Prezista
NDA #021976
Darunavir Ethanolate Tablet; Oral SUPPL-45 Janssen Prods Labeling Approved
Prezista
NDA #202895
Darunavir Ethanolate Suspension; Oral SUPPL-20 Janssen Prods Labeling Approved
Prezista
NDA #202895
Darunavir Ethanolate Suspension; Oral SUPPL-20 Janssen Prods Labeling Approved
Taclonex
NDA #022185
Betamethasone Dipropionate; Calcipotriene Hydrate Suspension; Topical SUPPL-25 Leo Pharma As Manufacturing (CMC) Approved

June 17, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Absorica
NDA #021951
Isotretinoin Capsule; Oral SUPPL-10 Ranbaxy REMS Approved
Amnesteem
ANDA #075945
Isotretinoin Capsule; Oral SUPPL-34 Mylan Pharms Inc REMS Approved
Claravis
ANDA #076135
Isotretinoin Capsule; Oral SUPPL-38 Teva Pharms Usa REMS Approved
Claravis
ANDA #076356
Isotretinoin Capsule; Oral SUPPL-35 Teva Pharms Usa REMS Approved
Myorisan
ANDA #076485
Isotretinoin Capsule; Oral SUPPL-15 Douglas Pharms REMS Approved
Zenatane
ANDA #202099
Isotretinoin Capsule; Oral SUPPL-9 Dr Reddys Labs Ltd REMS Approved

June 16, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Addyi
NDA #022526
Flibanserin Tablet; Oral SUPPL-4 Sprout Pharms REMS Approved
Aurovela 1/20
ANDA #207506
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-21 ORIG-1 Aurobindo Pharma Ltd Approved
Aurovela Fe 1/20
ANDA #207505
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-28 ORIG-1 Aurobindo Pharma Ltd Approved
Cisatracurium Besylate
ANDA #205873
Cisatracurium Besylate Injectable; Injection ORIG-1 Accord Hlthcare Approved
Cisatracurium Besylate Preservative Free
ANDA #205872
Cisatracurium Besylate Injectable; Injection ORIG-1 Accord Hlthcare Approved
Darzalex
BLA #761036
Daratumumab Injectable; Injection SUPPL-5 Janssen Biotech Efficacy Approved
Diflunisal
ANDA #203547
Diflunisal Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Eletriptan Hydrobromide
ANDA #206409
Eletriptan Hydrobromide Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Felbamate
ANDA #206314
Felbamate Suspension; Oral ORIG-1 Taro Pharm Approved
Her Style
ANDA #207976
Levonorgestrel Tablet; Oral SUPPL-1 Novast Labs Ltd Labeling Approved
Her Style
ANDA #207976
Levonorgestrel Tablet; Oral SUPPL-2 Novast Labs Ltd Labeling Approved
Her Style
ANDA #207976
Levonorgestrel Tablet; Oral SUPPL-1 Novast Labs Ltd Labeling Approved
Her Style
ANDA #207976
Levonorgestrel Tablet; Oral SUPPL-2 Novast Labs Ltd Labeling Approved
Lamotrigine
ANDA #078947
Lamotrigine Tablet; Oral SUPPL-22 Torrent Pharms Labeling Approved
Lamotrigine
ANDA #078947
Lamotrigine Tablet; Oral SUPPL-23 Torrent Pharms Labeling Approved
Linagliptin
ANDA #208415
Linagliptin Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Tentative Approval
Neuraceq
NDA #204677
Florbetaben F-18 Solution; Intravenous SUPPL-14 Piramal Imaging Labeling Approved
Niacin
ANDA #203899
Niacin Tablet, Extended Release; Oral ORIG-1 Lannett Approved
Olanzapine
ANDA #204866
Olanzapine Tablet; Oral ORIG-1 Hikma Pharms Llc Approved
Oxycodone and Acetaminophen
ANDA #201972
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-7 Aurolife Pharma Llc Labeling Approved
Oxycodone and Acetaminophen
ANDA #201972
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-7 Aurolife Pharma Llc Labeling Approved
Propranolol Hydrochloride
ANDA #070690
Propranolol Hydrochloride Solution; Oral SUPPL-21 West-Ward Pharms Int Labeling Approved
Sklice
NDA #202736
Ivermectin Lotion; Topical SUPPL-3 Arbor Pharms Llc Labeling Approved
Synercid
NDA #050747
Quinupristin; Dalfopristin Injectable; Injection SUPPL-15 King Pharms Labeling Approved
Synercid
NDA #050748
Dalfopristin; Quinupristin Injectable; Iv (Infusion) SUPPL-14 King Pharms Labeling Approved
Tafinlar
NDA #202806
Dabrafenib Mesylate Capsule; Oral SUPPL-7 Novartis Pharms Corp Labeling Approved
Testosterone Cypionate
ANDA #207742
Testosterone Cypionate Injectable; Injection ORIG-1 Luitpold Pharms Inc Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #076914
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-4 Watson Labs Labeling Approved
Xadago
NDA #207145
Safinamide Mesylate Tablet; Oral SUPPL-1 Us Worldmeds Llc Labeling Approved

June 15, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amantadine Hydrochloride
ANDA #209221
Amantadine Hydrochloride Capsule; Oral ORIG-1 Lannett Holdings Inc Approved
Aurovela 24 Fe
ANDA #207504
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Aurovela Fe 1.5/30
ANDA #207580
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-28 ORIG-1 Aurobindo Pharma Ltd Approved
Calcium Gluconate
NDA #208418
Calcium Gluconate Injectable; Injection ORIG-1 Fresenius Kabi Usa Type 7 - Drug Already Marketed without Approved NDA Approved
Glycopyrrolate
ANDA #208973
Glycopyrrolate Injectable; Injection ORIG-1 Amneal Pharms Co Approved
Invega Sustenna
NDA #022264
Paliperidone Palmitate Suspension, Extended Release; Intramuscular SUPPL-23 Janssen Pharms Labeling Approved
Kaletra
NDA #021226
Lopinavir; Ritonavir Capsule; Oral SUPPL-45 Abbvie Labeling Approved
Kaletra
NDA #021226
Lopinavir; Ritonavir Capsule; Oral SUPPL-45 Abbvie Labeling Approved
Kaletra
NDA #021251
Lopinavir; Ritonavir Solution; Oral SUPPL-54 Abbvie Labeling Approved
Kaletra
NDA #021251
Lopinavir; Ritonavir Solution; Oral SUPPL-54 Abbvie Labeling Approved
Kaletra
NDA #021906
Lopinavir; Ritonavir Tablet; Oral SUPPL-49 Abbvie Labeling Approved
Kaletra
NDA #021906
Lopinavir; Ritonavir Tablet; Oral SUPPL-49 Abbvie Labeling Approved
Metaxalone
ANDA #203695
Metaxalone Tablet; Oral ORIG-1 Actavis Labs Fl Inc Approved
Symjepi
NDA #207534
Epinephrine Injectable; Injection ORIG-1 Adamis Pharmaceuticals Corp Type 5 - New Formulation or New Manufacturer Approved
Vfend
NDA #021266
Voriconazole Tablet; Oral SUPPL-41 Pf Prism Cv Labeling Approved
Vfend
NDA #021267
Voriconazole Injectable; Iv (Infusion) SUPPL-53 Pf Prism Cv Labeling Approved
Vfend
NDA #021630
Voriconazole For Suspension; Oral SUPPL-31 Pf Prism Cv Labeling Approved
Zoloft
NDA #019839
Sertraline Hydrochloride Tablet; Oral SUPPL-88 Pfizer Labeling Approved
Zoloft
NDA #020990
Sertraline Hydrochloride Concentrate; Oral SUPPL-46 Pfizer Labeling Approved

June 14, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Calcitriol
ANDA #203289
Calcitriol Capsule; Oral ORIG-1 Amneal Pharms Approved
Doxycycline Hyclate
ANDA #208765
Doxycycline Hyclate Tablet; Oral ORIG-1 Mayne Pharma Inc Approved
Dysport
BLA #125274
Abobotulinumtoxina Injectable; Injection SUPPL-109 Ipsen Biopharm Ltd Efficacy Approved
Prezcobix
NDA #205395
Cobicistat; Darunavir Ethanolate Tablet; Oral SUPPL-4 Janssen Prods Labeling Approved
Prezcobix
NDA #205395
Cobicistat; Darunavir Ethanolate Tablet; Oral SUPPL-4 Janssen Prods Labeling Approved

June 13, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acyclovir Sodium
ANDA #206606
Acyclovir Sodium Injectable; Injection ORIG-1 Zydus Pharms Usa Inc Approved
Incruse Ellipta
NDA #205382
Umeclidinium Bromide Powder; Inhalation SUPPL-6 Glaxo Grp England Labeling Approved
Omeprazole
ANDA #204661
Omeprazole Capsule, Delayed Rel Pellets; Oral ORIG-1 Teva Pharms Usa Approved
Sevelamer Carbonate
ANDA #207624
Sevelamer Carbonate For Suspension; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Sular
NDA #020356
Nisoldipine Tablet, Extended Release; Oral SUPPL-27 Covis Pharma Bv Labeling Approved
Vermox
NDA #017481
Mebendazole Tablet, Chewable; Oral SUPPL-47 Janssen Pharms Labeling Approved
Zidovudine
ANDA #077981
Zidovudine Syrup; Oral SUPPL-24 Cipla Ltd Labeling Approved
Zidovudine
ANDA #077981
Zidovudine Syrup; Oral SUPPL-25 Cipla Ltd Labeling Approved

June 12, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Advil
NDA #201803
Ibuprofen Sodium Tablet; Oral SUPPL-8 Pfizer Cons Hlthcare Labeling Approved
Amantadine Hydrochloride
ANDA #209171
Amantadine Hydrochloride Capsule; Oral ORIG-1 Heritage Pharma Approved
Bendamustine Hydrochloride
ANDA #207149
Bendamustine Hydrochloride Injectable; Injection ORIG-1 Wockhardt Usa Tentative Approval
Bupropion Hydrochloride
ANDA #077285
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-34 Watson Labs Inc Labeling Approved
Bupropion Hydrochloride
ANDA #077285
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-34 Watson Labs Inc Labeling Approved
Bupropion Hydrochloride
ANDA #090325
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-13 Mylan Labeling Approved
Bupropion Hydrochloride
ANDA #090942
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-12 Mylan Labeling Approved
Bupropion Hydrochloride
ANDA #090942
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-13 Mylan Labeling Approved
Bupropion Hydrochloride
ANDA #090942
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-12 Mylan Labeling Approved
Bupropion Hydrochloride
ANDA #206556
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-3 Invagen Pharms Labeling Approved
Ezetimibe
ANDA #200831
Ezetimibe Tablet; Oral ORIG-1 Watson Labs Inc Approved
Ezetimibe
ANDA #203931
Ezetimibe Tablet; Oral ORIG-1 Sandoz Inc Approved
Ezetimibe
ANDA #204331
Ezetimibe Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Ezetimibe
ANDA #207311
Ezetimibe Tablet; Oral ORIG-1 Ohm Labs Inc Approved
Ezetimibe
ANDA #208332
Ezetimibe Tablet; Oral ORIG-1 Apotex Inc Approved
Ezetimibe
ANDA #208803
Ezetimibe Tablet; Oral ORIG-1 Amneal Pharms Co Approved
Intron A
BLA #103132
Interferon Alfa-2b Vial SUPPL-5195 Schering Labeling Approved
Itraconazole
ANDA #208591
Itraconazole Capsule; Oral ORIG-1 Alkem Labs Ltd Approved
Levetiracetam In Sodium Chloride
NDA #202543
Levetiracetam Injectable; Iv (Infusion) SUPPL-10 Hq Speciality Pharma Labeling Approved
Oxycodone Hydrochloride
ANDA #204021
Oxycodone Hydrochloride Tablet; Oral ORIG-1 Novel Labs Inc Approved
Saxagliptin
ANDA #205994
Saxagliptin Tablet; Oral ORIG-1 Glenmark Pharms Tentative Approval

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