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.

May 20, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Apokyn
NDA #021264
Apomorphine Hydrochloride Injectable; Subcutaneous SUPPL-16 Us Worldmeds Labeling Approved
Faslodex
NDA #021344
Fulvestrant Injectable; Intramuscular SUPPL-39 Astrazeneca Labeling Approved

May 17, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azelastine Hydrochloride
ANDA #091444
Azelastine Hydrochloride Spray, Metered; Nasal SUPPL-3 West-Ward Pharms Int Labeling Approved
Azelastine Hydrochloride
ANDA #207610
Azelastine Hydrochloride Spray, Metered; Nasal ORIG-1 Hi Tech Approved
Cinacalcet Hydrochloride
ANDA #210570
Cinacalcet Hydrochloride Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #211715
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral ORIG-1 Sun Pharm Industries Approved
Imipenem and Cilastatin
ANDA #090825
Cilastatin Sodium; Imipenem Powder; Intravenous SUPPL-11 Hospira Inc Labeling Approved
Imipenem and Cilastatin
ANDA #090825
Cilastatin Sodium; Imipenem Powder; Intravenous SUPPL-12 Hospira Inc Labeling Approved
Lurasidone Hydrochloride
ANDA #208060
Lurasidone Hydrochloride Tablet; Oral ORIG-1 Teva Pharms Usa Approved
Micafungin Sodium
ANDA #207344
Micafungin Sodium Injectable; Intravenous ORIG-1 Fresenius Kabi Usa Approved
Nayzilam
NDA #211321
Midazolam Spray; Nasal ORIG-1 Proximagen Llc Type 3 - New Dosage Form Approved
Orfadin
NDA #021232
Nitisinone Capsule; Oral SUPPL-23 Swedish Orphan Labeling Approved
Orfadin
NDA #206356
Nitisinone Suspension; Oral SUPPL-6 Swedish Orphan Labeling Approved
Plavix
NDA #020839
Clopidogrel Bisulfate Tablet; Oral SUPPL-72 Sanofi Aventis Us Labeling Approved
Sumatriptan Succinate
ANDA #078295
Sumatriptan Succinate Tablet; Oral SUPPL-8 Sun Pharm Inds Labeling Approved
Sumatriptan Succinate
ANDA #078295
Sumatriptan Succinate Tablet; Oral SUPPL-8 Sun Pharm Inds Labeling Approved
Sumatriptan Succinate
ANDA #078327
Sumatriptan Succinate Tablet; Oral SUPPL-11 Aurobindo Pharma Labeling Approved
Sumatriptan Succinate
ANDA #078327
Sumatriptan Succinate Tablet; Oral SUPPL-11 Aurobindo Pharma Labeling Approved
Telmisartan
ANDA #202397
Telmisartan Tablet; Oral SUPPL-6 Mylan Labeling Approved
Telmisartan
ANDA #202397
Telmisartan Tablet; Oral SUPPL-6 Mylan Labeling Approved
Telmisartan
ANDA #203867
Telmisartan Tablet; Oral SUPPL-7 Sandoz Inc Labeling Approved
Telmisartan
ANDA #208605
Telmisartan Tablet; Oral SUPPL-1 Cadila Pharms Ltd Labeling Approved
Zulresso
NDA #211371
Brexanolone Injectable; Injection SUPPL-1 Sage Therapeutics REMS Approved

May 16, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aggrastat
NDA #020912
Tirofiban Hydrochloride Injectable; Injection SUPPL-27 Medicure Labeling Approved
Aggrastat
NDA #020912
Tirofiban Hydrochloride Solution; Injection SUPPL-27 Medicure Labeling Approved
Aggrastat
NDA #020913
Tirofiban Hydrochloride Injectable; Injection SUPPL-26 Medicure Labeling Approved
Children's Cetirizine Hydrochloride Allergy
ANDA #212266
Cetirizine Hydrochloride Solution; Oral ORIG-1 Quagen Approved
Diclofenac Sodium
ANDA #211253
Diclofenac Sodium Gel; Topical ORIG-1 Gage Development Approved
Docetaxel
ANDA #210327
Docetaxel Injectable; Injection ORIG-1 Shilpa Medicare Ltd Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Injection SUPPL-72 Pfizer Inc Efficacy Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Subcutaneous SUPPL-72 Pfizer Inc Efficacy Approved
Gattex Kit
NDA #203441
Teduglutide Recombinant Powder; Subcutaneous SUPPL-13 Nps Pharms Inc Efficacy Approved
Herzuma
BLA #761091
Trastuzumab-Pkrb Injectable; Injection SUPPL-1 Celltrion Inc Manufacturing (CMC) Approved
Herzuma
BLA #761091
Trastuzumab-Pkrb Injectable; Injection SUPPL-2 Celltrion Inc Efficacy Approved
Jornay Pm
NDA #209311
Methylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-3 Ironshore Pharms Labeling Approved
Livalo
NDA #022363
Pitavastatin Calcium Tablet; Oral SUPPL-15 Kowa Co Efficacy Approved
Nevirapine
ANDA #203411
Nevirapine Tablet, Extended Release; Oral SUPPL-13 Sandoz Inc Efficacy Approved
Rivaroxaban
ANDA #208549
Rivaroxaban Unknown ORIG-1 Prinston Inc Tentative Approval
Testosterone
ANDA #204570
Testosterone Gel, Metered; Transdermal SUPPL-1 Actavis Labs Ut Inc Labeling Approved
Testosterone
ANDA #204570
Testosterone Gel, Metered; Transdermal SUPPL-1 Actavis Labs Ut Inc Labeling Approved
Tracleer
NDA #021290
Bosentan Tablet; Oral SUPPL-39 Actelion Pharms Ltd Labeling Approved
Tracleer
NDA #209279
Bosentan Tablet, For Suspension; Oral SUPPL-5 Actelion Pharms Labeling Approved
Tracleer
NDA #209279
Bosentan Tablet, For Suspension; Oral SUPPL-5 Actelion Pharms Labeling Approved

May 15, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Allopurinol
ANDA #071450
Allopurinol Tablet; Oral SUPPL-40 Sun Pharm Industries Labeling Approved
Antara (Micronized)
NDA #021695
Fenofibrate Capsule; Oral SUPPL-20 Lupin Atlantis Labeling Approved
Fenofibrate (Micronized)
ANDA #075753
Fenofibrate Capsule; Oral SUPPL-10 Rhodes Pharms Labeling Approved
Fenofibrate (Micronized)
ANDA #075868
Fenofibrate Capsule; Oral SUPPL-20 Impax Labs Labeling Approved
Fenofibrate (Micronized)
ANDA #202676
Fenofibrate Capsule; Oral SUPPL-5 Mylan Pharms Inc Labeling Approved
Fenofibrate (Micronized)
ANDA #205566
Fenofibrate Capsule; Oral SUPPL-3 Glenmark Pharms Ltd Labeling Approved
Fenofibrate (Micronized)
ANDA #207378
Fenofibrate Capsule; Oral SUPPL-4 Invagen Pharms Labeling Approved
Fenofibrate (Micronized)
ANDA #207805
Fenofibrate Capsule; Oral SUPPL-8 Austarpharma Labeling Approved
Fenofibrate (Micronized)
ANDA #209504
Fenofibrate Capsule; Oral SUPPL-4 Amerigen Pharms Ltd Labeling Approved
Fenofibrate (Micronized)
ANDA #210705
Fenofibrate Capsule; Oral SUPPL-1 Ajanta Pharma Ltd Labeling Approved
Fenofibrate (Micronized)
ANDA #210782
Fenofibrate Capsule; Oral SUPPL-1 Torrent Labeling Approved
Fenofibrate (Micronized)
ANDA #210782
Fenofibrate Capsule; Oral SUPPL-1 Torrent Labeling Approved
Fenoglide
NDA #022118
Fenofibrate Tablet; Oral SUPPL-10 Salix Labeling Approved
Fibricor
NDA #022418
Fenofibric Acid Tablet; Oral SUPPL-15 Athena Labeling Approved
Ibuprofen
ANDA #210149
Ibuprofen Suspension; Oral SUPPL-1 Guardian Drug Manufacturing (CMC) Approved
Lipofen
NDA #021612
Fenofibrate Capsule; Oral SUPPL-20 Cipher Pharms Inc Labeling Approved
Trelegy Ellipta
NDA #209482
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate Powder; Inhalation SUPPL-5 Glaxosmithkline Labeling Approved
Triglide
NDA #021350
Fenofibrate Tablet; Oral SUPPL-22 Skyepharma Ag Labeling Approved
Venclexta
NDA #208573
Venetoclax Tablet; Oral SUPPL-13 Abbvie Inc Efficacy Approved
Zoledronic Acid
ANDA #208513
Zoledronic Acid Injectable; Intravenous ORIG-1 Shilpa Medicare Ltd Approved

May 14, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Albendazole
ANDA #211117
Albendazole Tablet; Oral ORIG-1 Edenbridge Pharms Approved
Bavencio
BLA #761049
Avelumab Injectable; Injection SUPPL-6 Emd Serono Inc Efficacy Approved
Edurant
NDA #202022
Rilpivirine Hydrochloride Tablet; Oral SUPPL-13 Janssen Prods Labeling Approved
Fulvestrant
ANDA #205935
Fulvestrant Injectable; Intramuscular ORIG-1 Sandoz Inc Approved
Gemzar
NDA #020509
Gemcitabine Hydrochloride Injectable; Injection SUPPL-82 Lilly Labeling Approved
Glycopyrrolate
ANDA #211334
Glycopyrrolate Injectable; Injection ORIG-1 Sandoz Inc Approved
Vasostrict
NDA #204485
Vasopressin Solution; Intravenous SUPPL-9 Par Sterile Products Labeling Approved

May 13, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aleve
NDA #020204
Naproxen Sodium Tablet; Oral SUPPL-63 Bayer Labeling Approved
Aleve
NDA #020204
Naproxen Sodium Tablet; Oral SUPPL-64 Bayer Labeling Approved
Aleve
NDA #020204
Naproxen Sodium Tablet; Oral SUPPL-65 Bayer Labeling Approved
Corlanor
NDA #206143
Ivabradine Hydrochloride Tablet; Oral SUPPL-7 Amgen Inc Labeling Approved
Corlanor
NDA #206143
Ivabradine Hydrochloride Tablet; Oral SUPPL-7 Amgen Inc Labeling Approved
Doxorubicin Hydrochloride
ANDA #206062
Doxorubicin Hydrochloride Injectable; Injection ORIG-1 Hisun Pharm Hangzhou Approved
Entecavir
ANDA #202122
Entecavir Tablet; Oral SUPPL-3 Teva Pharms Usa Labeling Approved
Entecavir
ANDA #202122
Entecavir Tablet; Oral SUPPL-5 Teva Pharms Usa Labeling Approved
Entecavir
ANDA #202122
Entecavir Tablet; Oral SUPPL-7 Teva Pharms Usa Labeling Approved
Entecavir
ANDA #202122
Entecavir Tablet; Oral SUPPL-5 Teva Pharms Usa Labeling Approved
Entecavir
ANDA #202122
Entecavir Tablet; Oral SUPPL-7 Teva Pharms Usa Labeling Approved
Entecavir
ANDA #206872
Entecavir Tablet; Oral SUPPL-2 Cipla Labeling Approved
Entecavir
ANDA #206872
Entecavir Tablet; Oral SUPPL-3 Cipla Labeling Approved
Entecavir
ANDA #206872
Entecavir Tablet; Oral SUPPL-3 Cipla Labeling Approved
Entecavir
ANDA #208721
Entecavir Tablet; Oral SUPPL-1 Breckenridge Pharm Labeling Approved
Eylea
BLA #125387
Aflibercept Injectable; Injection SUPPL-61 Regeneron Pharmaceuticals Efficacy Approved
Fenofibrate (Micronized)
ANDA #209504
Fenofibrate Capsule; Oral SUPPL-2 Amerigen Pharms Ltd Labeling Approved
Labetalol Hydrochloride
ANDA #211325
Labetalol Hydrochloride Tablet; Oral ORIG-1 Cadila Pharms Ltd Approved
Neostigmine Methylsulfate
ANDA #212512
Neostigmine Methylsulfate Solution; Intravenous ORIG-1 Be Pharms Approved
Odomzo
NDA #205266
Sonidegib Phosphate Capsule; Oral SUPPL-6 Sun Pharma Global Labeling Approved
Risedronate Sodium
ANDA #205280
Risedronate Sodium Tablet; Oral ORIG-1 Orchid Hlthcare Approved

May 20, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Apokyn
NDA #021264
Apomorphine Hydrochloride Injectable; Subcutaneous SUPPL-16 Us Worldmeds Labeling Approved
Faslodex
NDA #021344
Fulvestrant Injectable; Intramuscular SUPPL-39 Astrazeneca Labeling Approved

May 17, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azelastine Hydrochloride
ANDA #091444
Azelastine Hydrochloride Spray, Metered; Nasal SUPPL-3 West-Ward Pharms Int Labeling Approved
Azelastine Hydrochloride
ANDA #207610
Azelastine Hydrochloride Spray, Metered; Nasal ORIG-1 Hi Tech Approved
Cinacalcet Hydrochloride
ANDA #210570
Cinacalcet Hydrochloride Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #211715
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral ORIG-1 Sun Pharm Industries Approved
Imipenem and Cilastatin
ANDA #090825
Cilastatin Sodium; Imipenem Powder; Intravenous SUPPL-11 Hospira Inc Labeling Approved
Imipenem and Cilastatin
ANDA #090825
Cilastatin Sodium; Imipenem Powder; Intravenous SUPPL-12 Hospira Inc Labeling Approved
Lurasidone Hydrochloride
ANDA #208060
Lurasidone Hydrochloride Tablet; Oral ORIG-1 Teva Pharms Usa Approved
Micafungin Sodium
ANDA #207344
Micafungin Sodium Injectable; Intravenous ORIG-1 Fresenius Kabi Usa Approved
Nayzilam
NDA #211321
Midazolam Spray; Nasal ORIG-1 Proximagen Llc Type 3 - New Dosage Form Approved
Orfadin
NDA #021232
Nitisinone Capsule; Oral SUPPL-23 Swedish Orphan Labeling Approved
Orfadin
NDA #206356
Nitisinone Suspension; Oral SUPPL-6 Swedish Orphan Labeling Approved
Plavix
NDA #020839
Clopidogrel Bisulfate Tablet; Oral SUPPL-72 Sanofi Aventis Us Labeling Approved
Sumatriptan Succinate
ANDA #078295
Sumatriptan Succinate Tablet; Oral SUPPL-8 Sun Pharm Inds Labeling Approved
Sumatriptan Succinate
ANDA #078295
Sumatriptan Succinate Tablet; Oral SUPPL-8 Sun Pharm Inds Labeling Approved
Sumatriptan Succinate
ANDA #078327
Sumatriptan Succinate Tablet; Oral SUPPL-11 Aurobindo Pharma Labeling Approved
Sumatriptan Succinate
ANDA #078327
Sumatriptan Succinate Tablet; Oral SUPPL-11 Aurobindo Pharma Labeling Approved
Telmisartan
ANDA #202397
Telmisartan Tablet; Oral SUPPL-6 Mylan Labeling Approved
Telmisartan
ANDA #202397
Telmisartan Tablet; Oral SUPPL-6 Mylan Labeling Approved
Telmisartan
ANDA #203867
Telmisartan Tablet; Oral SUPPL-7 Sandoz Inc Labeling Approved
Telmisartan
ANDA #208605
Telmisartan Tablet; Oral SUPPL-1 Cadila Pharms Ltd Labeling Approved
Zulresso
NDA #211371
Brexanolone Injectable; Injection SUPPL-1 Sage Therapeutics REMS Approved

May 16, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aggrastat
NDA #020912
Tirofiban Hydrochloride Injectable; Injection SUPPL-27 Medicure Labeling Approved
Aggrastat
NDA #020912
Tirofiban Hydrochloride Solution; Injection SUPPL-27 Medicure Labeling Approved
Aggrastat
NDA #020913
Tirofiban Hydrochloride Injectable; Injection SUPPL-26 Medicure Labeling Approved
Children's Cetirizine Hydrochloride Allergy
ANDA #212266
Cetirizine Hydrochloride Solution; Oral ORIG-1 Quagen Approved
Diclofenac Sodium
ANDA #211253
Diclofenac Sodium Gel; Topical ORIG-1 Gage Development Approved
Docetaxel
ANDA #210327
Docetaxel Injectable; Injection ORIG-1 Shilpa Medicare Ltd Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Injection SUPPL-72 Pfizer Inc Efficacy Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Subcutaneous SUPPL-72 Pfizer Inc Efficacy Approved
Gattex Kit
NDA #203441
Teduglutide Recombinant Powder; Subcutaneous SUPPL-13 Nps Pharms Inc Efficacy Approved
Herzuma
BLA #761091
Trastuzumab-Pkrb Injectable; Injection SUPPL-1 Celltrion Inc Manufacturing (CMC) Approved
Herzuma
BLA #761091
Trastuzumab-Pkrb Injectable; Injection SUPPL-2 Celltrion Inc Efficacy Approved
Jornay Pm
NDA #209311
Methylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-3 Ironshore Pharms Labeling Approved
Livalo
NDA #022363
Pitavastatin Calcium Tablet; Oral SUPPL-15 Kowa Co Efficacy Approved
Nevirapine
ANDA #203411
Nevirapine Tablet, Extended Release; Oral SUPPL-13 Sandoz Inc Efficacy Approved
Rivaroxaban
ANDA #208549
Rivaroxaban Unknown ORIG-1 Prinston Inc Tentative Approval
Testosterone
ANDA #204570
Testosterone Gel, Metered; Transdermal SUPPL-1 Actavis Labs Ut Inc Labeling Approved
Testosterone
ANDA #204570
Testosterone Gel, Metered; Transdermal SUPPL-1 Actavis Labs Ut Inc Labeling Approved
Tracleer
NDA #021290
Bosentan Tablet; Oral SUPPL-39 Actelion Pharms Ltd Labeling Approved
Tracleer
NDA #209279
Bosentan Tablet, For Suspension; Oral SUPPL-5 Actelion Pharms Labeling Approved
Tracleer
NDA #209279
Bosentan Tablet, For Suspension; Oral SUPPL-5 Actelion Pharms Labeling Approved

May 15, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Allopurinol
ANDA #071450
Allopurinol Tablet; Oral SUPPL-40 Sun Pharm Industries Labeling Approved
Antara (Micronized)
NDA #021695
Fenofibrate Capsule; Oral SUPPL-20 Lupin Atlantis Labeling Approved
Fenofibrate (Micronized)
ANDA #075753
Fenofibrate Capsule; Oral SUPPL-10 Rhodes Pharms Labeling Approved
Fenofibrate (Micronized)
ANDA #075868
Fenofibrate Capsule; Oral SUPPL-20 Impax Labs Labeling Approved
Fenofibrate (Micronized)
ANDA #202676
Fenofibrate Capsule; Oral SUPPL-5 Mylan Pharms Inc Labeling Approved
Fenofibrate (Micronized)
ANDA #205566
Fenofibrate Capsule; Oral SUPPL-3 Glenmark Pharms Ltd Labeling Approved
Fenofibrate (Micronized)
ANDA #207378
Fenofibrate Capsule; Oral SUPPL-4 Invagen Pharms Labeling Approved
Fenofibrate (Micronized)
ANDA #207805
Fenofibrate Capsule; Oral SUPPL-8 Austarpharma Labeling Approved
Fenofibrate (Micronized)
ANDA #209504
Fenofibrate Capsule; Oral SUPPL-4 Amerigen Pharms Ltd Labeling Approved
Fenofibrate (Micronized)
ANDA #210705
Fenofibrate Capsule; Oral SUPPL-1 Ajanta Pharma Ltd Labeling Approved
Fenofibrate (Micronized)
ANDA #210782
Fenofibrate Capsule; Oral SUPPL-1 Torrent Labeling Approved
Fenofibrate (Micronized)
ANDA #210782
Fenofibrate Capsule; Oral SUPPL-1 Torrent Labeling Approved
Fenoglide
NDA #022118
Fenofibrate Tablet; Oral SUPPL-10 Salix Labeling Approved
Fibricor
NDA #022418
Fenofibric Acid Tablet; Oral SUPPL-15 Athena Labeling Approved
Ibuprofen
ANDA #210149
Ibuprofen Suspension; Oral SUPPL-1 Guardian Drug Manufacturing (CMC) Approved
Lipofen
NDA #021612
Fenofibrate Capsule; Oral SUPPL-20 Cipher Pharms Inc Labeling Approved
Trelegy Ellipta
NDA #209482
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate Powder; Inhalation SUPPL-5 Glaxosmithkline Labeling Approved
Triglide
NDA #021350
Fenofibrate Tablet; Oral SUPPL-22 Skyepharma Ag Labeling Approved
Venclexta
NDA #208573
Venetoclax Tablet; Oral SUPPL-13 Abbvie Inc Efficacy Approved
Zoledronic Acid
ANDA #208513
Zoledronic Acid Injectable; Intravenous ORIG-1 Shilpa Medicare Ltd Approved

May 14, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Albendazole
ANDA #211117
Albendazole Tablet; Oral ORIG-1 Edenbridge Pharms Approved
Bavencio
BLA #761049
Avelumab Injectable; Injection SUPPL-6 Emd Serono Inc Efficacy Approved
Edurant
NDA #202022
Rilpivirine Hydrochloride Tablet; Oral SUPPL-13 Janssen Prods Labeling Approved
Fulvestrant
ANDA #205935
Fulvestrant Injectable; Intramuscular ORIG-1 Sandoz Inc Approved
Gemzar
NDA #020509
Gemcitabine Hydrochloride Injectable; Injection SUPPL-82 Lilly Labeling Approved
Glycopyrrolate
ANDA #211334
Glycopyrrolate Injectable; Injection ORIG-1 Sandoz Inc Approved
Vasostrict
NDA #204485
Vasopressin Solution; Intravenous SUPPL-9 Par Sterile Products Labeling Approved

May 13, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aleve
NDA #020204
Naproxen Sodium Tablet; Oral SUPPL-63 Bayer Labeling Approved
Aleve
NDA #020204
Naproxen Sodium Tablet; Oral SUPPL-64 Bayer Labeling Approved
Aleve
NDA #020204
Naproxen Sodium Tablet; Oral SUPPL-65 Bayer Labeling Approved
Corlanor
NDA #206143
Ivabradine Hydrochloride Tablet; Oral SUPPL-7 Amgen Inc Labeling Approved
Corlanor
NDA #206143
Ivabradine Hydrochloride Tablet; Oral SUPPL-7 Amgen Inc Labeling Approved
Doxorubicin Hydrochloride
ANDA #206062
Doxorubicin Hydrochloride Injectable; Injection ORIG-1 Hisun Pharm Hangzhou Approved
Entecavir
ANDA #202122
Entecavir Tablet; Oral SUPPL-3 Teva Pharms Usa Labeling Approved
Entecavir
ANDA #202122
Entecavir Tablet; Oral SUPPL-5 Teva Pharms Usa Labeling Approved
Entecavir
ANDA #202122
Entecavir Tablet; Oral SUPPL-7 Teva Pharms Usa Labeling Approved
Entecavir
ANDA #202122
Entecavir Tablet; Oral SUPPL-5 Teva Pharms Usa Labeling Approved
Entecavir
ANDA #202122
Entecavir Tablet; Oral SUPPL-7 Teva Pharms Usa Labeling Approved
Entecavir
ANDA #206872
Entecavir Tablet; Oral SUPPL-2 Cipla Labeling Approved
Entecavir
ANDA #206872
Entecavir Tablet; Oral SUPPL-3 Cipla Labeling Approved
Entecavir
ANDA #206872
Entecavir Tablet; Oral SUPPL-3 Cipla Labeling Approved
Entecavir
ANDA #208721
Entecavir Tablet; Oral SUPPL-1 Breckenridge Pharm Labeling Approved
Eylea
BLA #125387
Aflibercept Injectable; Injection SUPPL-61 Regeneron Pharmaceuticals Efficacy Approved
Fenofibrate (Micronized)
ANDA #209504
Fenofibrate Capsule; Oral SUPPL-2 Amerigen Pharms Ltd Labeling Approved
Labetalol Hydrochloride
ANDA #211325
Labetalol Hydrochloride Tablet; Oral ORIG-1 Cadila Pharms Ltd Approved
Neostigmine Methylsulfate
ANDA #212512
Neostigmine Methylsulfate Solution; Intravenous ORIG-1 Be Pharms Approved
Odomzo
NDA #205266
Sonidegib Phosphate Capsule; Oral SUPPL-6 Sun Pharma Global Labeling Approved
Risedronate Sodium
ANDA #205280
Risedronate Sodium Tablet; Oral ORIG-1 Orchid Hlthcare Approved

May 10, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Anafranil
NDA #019906
Clomipramine Hydrochloride Capsule; Oral SUPPL-43 Specgx Llc Labeling Approved
Androgel
NDA #021015
Testosterone Gel, Metered; Transdermal SUPPL-45 Abbvie Labeling Approved
Androgel
NDA #021015
Testosterone Gel; Transdermal SUPPL-45 Abbvie Labeling Approved
Androgel
NDA #022309
Testosterone Gel, Metered; Transdermal SUPPL-20 Abbvie Labeling Approved
Androgel
NDA #022309
Testosterone Gel; Transdermal SUPPL-20 Abbvie Labeling Approved
Caduet
NDA #021540
Amlodipine Besylate; Atorvastatin Calcium Tablet; Oral SUPPL-44 Pfizer Labeling Approved
Chlorthalidone
ANDA #207813
Chlorthalidone Tablet; Oral ORIG-1 Zydus Pharms Approved
Combivir
NDA #020857
Lamivudine; Zidovudine Tablet; Oral SUPPL-34 Viiv Hlthcare Labeling Approved
Cyramza
BLA #125477
Ramucirumab Injectable; Injection SUPPL-29 Eli Lilly and Co Efficacy Approved
Dexamethasone Sodium Phosphate
ANDA #211036
Dexamethasone Sodium Phosphate Injectable; Injection ORIG-1 Somerset Theraps Llc Approved
Epivir
NDA #020564
Lamivudine Tablet; Oral SUPPL-39 Viiv Hlthcare Labeling Approved
Epivir
NDA #020564
Lamivudine Tablet; Oral SUPPL-39 Viiv Hlthcare Labeling Approved
Epivir
NDA #020596
Lamivudine Solution; Oral SUPPL-38 Viiv Hlthcare Labeling Approved
Epivir
NDA #020596
Lamivudine Solution; Oral SUPPL-38 Viiv Hlthcare Labeling Approved
Epzicom
NDA #021652
Abacavir Sulfate; Lamivudine Tablet; Oral SUPPL-24 Viiv Hlthcare Labeling Approved
Epzicom
NDA #021652
Abacavir Sulfate; Lamivudine Tablet; Oral SUPPL-24 Viiv Hlthcare Labeling Approved
Esomeprazole Magnesium
ANDA #209495
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral ORIG-1 Glenmark Pharms Approved
Fortesta
NDA #021463
Testosterone Gel, Metered; Transdermal SUPPL-20 Endo Pharms Labeling Approved
Fortesta
NDA #021463
Testosterone Gel, Metered; Transdermal SUPPL-20 Endo Pharms Labeling Approved
Lansoprazole
ANDA #091269
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-13 Dr Reddys Labs Ltd Labeling Approved
Lansoprazole
ANDA #091269
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-16 Dr Reddys Labs Ltd Labeling Approved
Lansoprazole
ANDA #091269
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-8 Dr Reddys Labs Ltd Labeling Approved
Lansoprazole
ANDA #091269
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-12 Dr Reddys Labs Ltd Labeling Approved
Lansoprazole
ANDA #091269
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-13 Dr Reddys Labs Ltd Labeling Approved
Lansoprazole
ANDA #091269
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-14 Dr Reddys Labs Ltd Labeling Approved
Lansoprazole
ANDA #091269
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-16 Dr Reddys Labs Ltd Labeling Approved
Lansoprazole
ANDA #202176
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-8 Wockhardt Usa Labeling Approved
Lansoprazole
ANDA #202176
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-7 Wockhardt Usa Labeling Approved
Lansoprazole
ANDA #202176
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-8 Wockhardt Usa Labeling Approved
Naproxen Sodium and Diphenhydramine Hydrochloride
ANDA #208499
Diphenhydramine Hydrochloride; Naproxen Sodium Tablet; Oral ORIG-1 Perrigo R and D Approved
Nuplazid
NDA #207318
Pimavanserin Tartrate Tablet; Oral SUPPL-7 Acadia Pharms Inc Labeling Approved
Nuplazid
NDA #210793
Pimavanserin Tartrate Capsule; Oral SUPPL-2 Acadia Pharms Inc Labeling Approved
Oxybutynin Chloride
ANDA #211682
Oxybutynin Chloride Tablet; Oral ORIG-1 Emcure Pharms Ltd Approved
Sapropterin Dihydrochloride
ANDA #207200
Sapropterin Dihydrochloride Tablet; Oral ORIG-1 Par Pharm Inc Approved
Testim
NDA #021454
Testosterone Gel; Transdermal SUPPL-27 Auxilium Pharms Llc Labeling Approved
Testim
NDA #021454
Testosterone Gel; Transdermal SUPPL-27 Auxilium Pharms Llc Labeling Approved
Testosterone
ANDA #204255
Testosterone Solution, Metered; Transdermal SUPPL-4 Perrigo Israel Labeling Approved
Testosterone
ANDA #204255
Testosterone Solution, Metered; Transdermal SUPPL-4 Perrigo Israel Labeling Approved
Testosterone
ANDA #205328
Testosterone Solution, Metered; Transdermal SUPPL-1 Actavis Labs Ut Inc Labeling Approved
Testosterone
ANDA #205328
Testosterone Solution, Metered; Transdermal SUPPL-1 Actavis Labs Ut Inc Labeling Approved
Testosterone
ANDA #208061
Testosterone Solution, Metered; Transdermal SUPPL-1 Lupin Ltd Labeling Approved
Testosterone
ANDA #208061
Testosterone Solution, Metered; Transdermal SUPPL-1 Lupin Ltd Labeling Approved
Testosterone
ANDA #209533
Testosterone Solution, Metered; Transdermal SUPPL-3 Cipla Labeling Approved
Trizivir
NDA #021205
Abacavir Sulfate; Lamivudine; Zidovudine Tablet; Oral SUPPL-38 Viiv Hlthcare Labeling Approved
Trizivir
NDA #021205
Abacavir Sulfate; Lamivudine; Zidovudine Tablet; Oral SUPPL-38 Viiv Hlthcare Labeling Approved
Vogelxo
NDA #204399
Testosterone Gel, Metered; Transdermal SUPPL-10 Upsher Smith Labs Labeling Approved
Vogelxo
NDA #204399
Testosterone Gel; Transdermal SUPPL-10 Upsher Smith Labs Labeling Approved
Xeomin
BLA #125360
Incobotulinumtoxina Injectable; Injection SUPPL-74 Merz Pharms Efficacy Approved
Zosyn
NDA #050684
Piperacillin Sodium; Tazobactam Sodium Injectable; Injection SUPPL-94 Wyeth Pharms Labeling Approved
Zosyn In Plastic Container
NDA #050750
Piperacillin Sodium; Tazobactam Sodium Injectable; Injection SUPPL-41 Wyeth Pharms Labeling Approved

May 9, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Armodafinil
ANDA #200043
Armodafinil Tablet; Oral ORIG-2 Mylan Pharms Inc Approved
Creon
NDA #020725
Pancrelipase (Amylase;Lipase;Protease) Capsule, Delayed Release; Oral SUPPL-25 Abbvie Labeling Approved
Hydroxyprogesterone Caproate
ANDA #211142
Hydroxyprogesterone Caproate Solution; Intramuscular ORIG-1 Eugia Pharma Approved
Lacosamide
ANDA #209301
Lacosamide Unknown ORIG-1 Hetero Labs Unit Iii Tentative Approval
Lantus
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-72 Sanofi Aventis Us Labeling Approved
Lantus Solostar
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-72 Sanofi Aventis Us Labeling Approved
Mesalamine
ANDA #207873
Mesalamine Capsule, Delayed Release; Oral ORIG-1 Teva Pharms Usa Approved
Spravato
NDA #211243
Esketamine Spray; Nasal SUPPL-1 Janssen Pharms Labeling Approved
Spravato
NDA #211243
Esketamine Hydrochloride Spray; Nasal SUPPL-1 Janssen Pharms Labeling Approved

May 8, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bethanechol Chloride
ANDA #040725
Bethanechol Chloride Tablet; Oral SUPPL-2 Eci Pharms Llc Manufacturing (CMC) Approved
Bethanechol Chloride
ANDA #040726
Bethanechol Chloride Tablet; Oral SUPPL-2 Eci Pharms Llc Manufacturing (CMC) Approved
Bethanechol Chloride
ANDA #040727
Bethanechol Chloride Tablet; Oral SUPPL-2 Eci Pharms Llc Manufacturing (CMC) Approved
Bethanechol Chloride
ANDA #040728
Bethanechol Chloride Tablet; Oral SUPPL-2 Eci Pharms Llc Manufacturing (CMC) Approved
Busulfan
ANDA #207050
Busulfan Injectable; Injection SUPPL-1 Pharmascience Inc Labeling Approved
Busulfan
ANDA #207050
Busulfan Injectable; Injection SUPPL-2 Pharmascience Inc Labeling Approved
Dapsone
ANDA #207165
Dapsone Tablet; Oral ORIG-1 Sai Life Sciences Approved
Decadron
NDA #011664
Dexamethasone Tablet; Oral SUPPL-64 Merck Labeling Approved
Eszopiclone
ANDA #203087
Eszopiclone Tablet; Oral ORIG-1 Breckenridge Pharm Approved
Lo/Ovral-28
NDA #017802
Ethinyl Estradiol; Norgestrel Tablet; Oral-28 SUPPL-34 Wyeth Pharms Labeling Approved
Norminest Fe
NDA #017948
Ethinyl Estradiol;Norethindrone; Ferrous Fumarate Tablet; Oral SUPPL-46 Gd Searle Llc Labeling Approved
Norquest Fe
NDA #018926
Ethinyl Estradiol; Ferrous Fumarate; Norethindrone Tablet; Oral-28 SUPPL-13 Gd Searle Llc Labeling Approved
Nuvaring
NDA #021187
Ethinyl Estradiol; Etonogestrel Ring; Vaginal SUPPL-37 Organon Sub Merck Labeling Approved
Omnaris
NDA #022004
Ciclesonide Spray, Metered; Nasal SUPPL-18 Covis Pharma Bv Labeling Approved
Prolia
BLA #125320
Denosumab Injectable; Subcutaneous SUPPL-196 Amgen Labeling Approved
Prolia
BLA #125320
Denosumab Injectable; Subcutaneous SUPPL-199 Amgen Labeling Approved
Triphasil-21
NDA #019192
Ethinyl Estradiol; Levonorgestrel Tablet; Oral-21 SUPPL-48 Wyeth Pharms Labeling Approved
Triphasil-28
NDA #019190
Ethinyl Estradiol; Levonorgestrel Tablet; Oral-28 SUPPL-49 Wyeth Pharms Inc Labeling Approved
Xgeva
BLA #125320
Denosumab Injectable; Subcutaneous SUPPL-196 Amgen Labeling Approved
Xgeva
BLA #125320
Denosumab Injectable; Subcutaneous SUPPL-199 Amgen Labeling Approved
Yervoy
BLA #125377
Ipilimumab Injectable; Injection SUPPL-102 Bristol Myers Squibb Labeling Approved

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