Drugs@FDA: FDA Approved Drug Products

Recent New and Generic Drug Approvals

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

September 18, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Biaxin
NDA #050662
Clarithromycin Tablet; Oral SUPPL-61 Abbvie Labeling Approved
Biaxin
NDA #050698
Clarithromycin For Suspension; Oral SUPPL-41 Abbvie Labeling Approved
Biaxin Xl
NDA #050775
Clarithromycin Tablet, Extended Release; Oral SUPPL-29 Abbvie Labeling Approved
Daptomycin
NDA #209949
Daptomycin Powder; Iv (Infusion) SUPPL-3 Xellia Pharms Aps Labeling Approved
Opdivo
BLA #125554
Nivolumab Injectable; Injection SUPPL-75 Bristol Myers Squibb Labeling Approved

September 17, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Erleada
NDA #210951
Apalutamide Tablet; Oral SUPPL-1 Janssen Biotech Efficacy Approved
Keytruda
BLA #125514
Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-65 Merck Sharp Dohme Efficacy Approved
Lenvima
NDA #206947
Lenvatinib Mesylate Capsule; Oral SUPPL-11 Eisai Inc Efficacy Approved
Pantoprazole Sodium
ANDA #205675
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #205675
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-5 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #205675
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #205675
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-8 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #205675
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-11 Aurobindo Pharma Ltd Labeling Approved
Tacrolimus
ANDA #065461
Tacrolimus Capsule; Oral SUPPL-32 Sandoz Labeling Approved
Tacrolimus
ANDA #065461
Tacrolimus Capsule; Oral SUPPL-32 Sandoz Labeling Approved
Thalitone
NDA #019574
Chlorthalidone Tablet; Oral SUPPL-17 Casper Pharma Llc Labeling Approved

September 16, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cleocin
NDA #050767
Clindamycin Phosphate Suppository; Vaginal SUPPL-16 Pharmacia and Upjohn Labeling Approved
Ezetimibe and Simvastatin
ANDA #202968
Ezetimibe; Simvastatin Tablet; Oral SUPPL-2 Watson Labs Inc Labeling Approved
Ezetimibe and Simvastatin
ANDA #202968
Ezetimibe; Simvastatin Tablet; Oral SUPPL-3 Watson Labs Inc Labeling Approved
Ezetimibe and Simvastatin
ANDA #202968
Ezetimibe; Simvastatin Tablet; Oral SUPPL-2 Watson Labs Inc Labeling Approved
Ezetimibe and Simvastatin
ANDA #202968
Ezetimibe; Simvastatin Tablet; Oral SUPPL-3 Watson Labs Inc Labeling Approved
Onpattro
NDA #210922
Patisiran Sodium Solution; Intravenous SUPPL-4 Alnylam Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090296
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-2 Sandoz Inc Labeling Approved
Pantoprazole Sodium
ANDA #090296
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-3 Sandoz Inc Labeling Approved
Pantoprazole Sodium
ANDA #090296
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-5 Sandoz Inc Labeling Approved
Pantoprazole Sodium
ANDA #090296
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-6 Sandoz Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-17 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-14 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-17 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-7 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-2 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-3 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-4 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-7 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-2 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-3 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-4 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-5 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-7 Amneal Pharms Labeling Approved

September 15, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Mesna
ANDA #075811
Mesna Injectable; Intravenous SUPPL-14 Fresenius Kabi Usa Labeling Approved

September 13, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Anastrozole
ANDA #091051
Anastrozole Tablet; Oral SUPPL-7 Mylan Labeling Approved
Anastrozole
ANDA #091051
Anastrozole Tablet; Oral SUPPL-7 Mylan Labeling Approved
Benlysta
BLA #125370
Belimumab Injectable; Injection SUPPL-67 Human Genome Sciences Inc. Labeling Approved
Benlysta
BLA #761043
Belimumab Injectable; Injection SUPPL-5 Glaxosmithkline Llc Labeling Approved
Cyltezo
BLA #761058
Adalimumab-Adbm Injectable; Injection SUPPL-3 Boehringer Ingelheim Labeling Approved
Dolutegravir Sodium
ANDA #212179
Dolutegravir Sodium Unknown ORIG-1 Micro Labs Ltd Tentative Approval
Ivermectin
ANDA #210019
Ivermectin Cream; Topical ORIG-1 Teva Pharms Usa Inc Approved
Levocetirizine Dihydrochloride
ANDA #205564
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-5 Macleods Pharms Ltd Labeling Approved
Levocetirizine Dihydrochloride
ANDA #205564
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-10 Macleods Pharms Ltd Labeling Approved
Levocetirizine Dihydrochloride
ANDA #205564
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-13 Macleods Pharms Ltd Labeling Approved
Mydayis
NDA #022063
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-1 Shire Dev Llc Efficacy Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-8 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-10 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-8 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-10 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Macleods Pharms Ltd Labeling Approved
Teflaro
NDA #200327
Ceftaroline Fosamil Powder; Intravenous SUPPL-22 Allergan Sales Llc Efficacy Approved
Tranexamic Acid
ANDA #202436
Tranexamic Acid Injectable; Injection SUPPL-3 Acic Pharms Labeling Approved
Valsartan
ANDA #091367
Valsartan Tablet; Oral SUPPL-5 Alembic Pharms Ltd Labeling Approved
Valsartan
ANDA #091367
Valsartan Tablet; Oral SUPPL-11 Alembic Pharms Ltd Labeling Approved
Valsartan
ANDA #091367
Valsartan Tablet; Oral SUPPL-11 Alembic Pharms Ltd Labeling Approved
Zulresso
NDA #211371
Brexanolone Solution; Intravenous SUPPL-2 Sage Therap Labeling Approved

September 12, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-2 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-2 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-4 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-5 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-2 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-3 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-4 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-5 Amneal Pharms Labeling Approved
Ditropan Xl
NDA #020897
Oxybutynin Chloride Tablet, Extended Release; Oral SUPPL-37 Janssen Pharms Labeling Approved
Ibsrela
NDA #211801
Tenapanor Tablet; Oral ORIG-1 Ardelyx Inc Type 1 - New Molecular Entity Approved
Nucala
BLA #125526
Mepolizumab Injectable; Subcutaneous Lyophilized Power SUPPL-12 Glaxosmithkline Llc Efficacy Approved
Nucala
BLA #761122
Mepolizumab Injectable; Subcutaneous SUPPL-3 Glaxosmithkline Efficacy Approved
Nucala
BLA #761122
Mepolizumab Injectable; Subcutaneous SUPPL-2 Glaxosmithkline Labeling Approved
Nucala
BLA #761122
Mepolizumab Injectable; Subcutaneous SUPPL-2 Glaxosmithkline Labeling Approved
Sabril
NDA #020427
Vigabatrin Tablet; Oral SUPPL-22 Lundbeck Pharms Llc REMS Approved
Sabril
NDA #022006
Vigabatrin For Solution; Oral SUPPL-24 Lundbeck Pharms Llc REMS Approved
Vigabatrin
ANDA #208218
Vigabatrin For Solution; Oral SUPPL-7 Par Pharm Inc REMS Approved
Vigabatrin
ANDA #209822
Vigabatrin Tablet; Oral SUPPL-4 Teva Pharms Usa REMS Approved
Vigabatrin
ANDA #209824
Vigabatrin For Solution; Oral SUPPL-5 Teva Pharms Usa REMS Approved
Vigabatrin
ANDA #210155
Vigabatrin For Solution; Oral SUPPL-4 Amneal Pharms REMS Approved
Vigabatrin
ANDA #211481
Vigabatrin For Solution; Oral SUPPL-2 Dr Reddys Labs Ltd REMS Approved
Vigadrone
ANDA #210196
Vigabatrin For Solution; Oral SUPPL-3 Aucta REMS Approved

September 11, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amantadine Hydrochloride
ANDA #071293
Amantadine Hydrochloride Capsule; Oral SUPPL-40 Sandoz Manufacturing (CMC) Approved
Amantadine Hydrochloride
ANDA #071293
Amantadine Hydrochloride Capsule; Oral SUPPL-38 Sandoz Labeling Approved
Dapagliflozin
ANDA #211482
Dapagliflozin Unknown ORIG-1 Ajanta Pharma Ltd Tentative Approval
Dolutegavir; Lamivudine; Tenofovir Alafenamide Fumarate
NDA #210865
Dolutegavir;Lamivudine;Tenofovir Alafenamide Fumarate Unknown ORIG-1 Mylan Labs Ltd Type 4 - New Combination Tentative Approval
Famotidine
ANDA #206531
Famotidine Tablet; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Famotidine
ANDA #206531
Famotidine Tablet; Oral SUPPL-7 Aurobindo Pharma Ltd Labeling Approved
Famotidine
ANDA #206531
Famotidine Tablet; Oral SUPPL-7 Aurobindo Pharma Ltd Labeling Approved
Indomethacin
ANDA #073314
Indomethacin Suppository; Rectal SUPPL-22 Acp Nimble Labeling Approved
Indomethacin
ANDA #073314
Indomethacin Suppository; Rectal SUPPL-22 Acp Nimble Labeling Approved
Indomethacin
ANDA #073314
Indomethacin Suppository; Rectal SUPPL-23 Acp Nimble Labeling Approved
Mycophenolate Mofetil
ANDA #065379
Mycophenolate Mofetil Capsule; Oral SUPPL-22 Sandoz Labeling Approved
Mycophenolate Mofetil
ANDA #065379
Mycophenolate Mofetil Capsule; Oral SUPPL-22 Sandoz Labeling Approved
Mycophenolate Mofetil
ANDA #065379
Mycophenolate Mofetil Capsule; Oral SUPPL-24 Sandoz Labeling Approved
Mycophenolate Mofetil
ANDA #065416
Mycophenolate Mofetil Tablet; Oral SUPPL-16 Accord Hlthcare Labeling Approved
Mycophenolate Mofetil
ANDA #065451
Mycophenolate Mofetil Tablet; Oral SUPPL-22 Sandoz Labeling Approved
Mycophenolate Mofetil
ANDA #065451
Mycophenolate Mofetil Tablet; Oral SUPPL-25 Sandoz Labeling Approved
Mycophenolate Mofetil
ANDA #065520
Mycophenolate Mofetil Capsule; Oral SUPPL-20 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #065520
Mycophenolate Mofetil Capsule; Oral SUPPL-22 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #065520
Mycophenolate Mofetil Capsule; Oral SUPPL-20 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #065520
Mycophenolate Mofetil Capsule; Oral SUPPL-22 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #065521
Mycophenolate Mofetil Tablet; Oral SUPPL-20 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #065521
Mycophenolate Mofetil Tablet; Oral SUPPL-18 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #065521
Mycophenolate Mofetil Tablet; Oral SUPPL-20 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #090253
Mycophenolate Mofetil Capsule; Oral SUPPL-16 Accord Hlthcare Labeling Approved
Oxaprozin
ANDA #075855
Oxaprozin Tablet; Oral SUPPL-8 Dr Reddys Labs Ltd Labeling Approved
Oxaprozin
ANDA #075855
Oxaprozin Tablet; Oral SUPPL-9 Dr Reddys Labs Ltd Labeling Approved
Oxaprozin
ANDA #075855
Oxaprozin Tablet; Oral SUPPL-8 Dr Reddys Labs Ltd Labeling Approved
Oxaprozin
ANDA #075855
Oxaprozin Tablet; Oral SUPPL-9 Dr Reddys Labs Ltd Labeling Approved
Paxil Cr
NDA #020936
Paroxetine Hydrochloride Tablet, Extended Release; Oral SUPPL-47 Apotex Technologies Labeling Approved

September 10, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aczone
NDA #207154
Dapsone Gel; Topical SUPPL-4 Almirall Efficacy Approved
Aczone
NDA #207154
Dapsone Gel; Topical SUPPL-4 Almirall Efficacy Approved
Altabax
NDA #022055
Retapamulin Ointment; Topical SUPPL-7 Almirall Labeling Approved
Apixaban
ANDA #209944
Apixaban Tablet; Oral ORIG-1 Sunshine Lake Tentative Approval
Gvoke
NDA #212097
Glucagon Injectable; Injection ORIG-1 Xeris Pharma Inc Type 3 - New Dosage Form Approved
Mycophenolate Mofetil
ANDA #065491
Mycophenolate Mofetil Capsule; Oral SUPPL-17 Teva Pharms Labeling Approved
Mycophenolate Mofetil
ANDA #065491
Mycophenolate Mofetil Capsule; Oral SUPPL-18 Teva Pharms Labeling Approved
Mycophenolate Mofetil
ANDA #065491
Mycophenolate Mofetil Capsule; Oral SUPPL-17 Teva Pharms Labeling Approved
Mycophenolate Mofetil
ANDA #065491
Mycophenolate Mofetil Capsule; Oral SUPPL-18 Teva Pharms Labeling Approved
Mycophenolate Mofetil
ANDA #091249
Mycophenolate Mofetil Tablet; Oral SUPPL-14 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #091249
Mycophenolate Mofetil Tablet; Oral SUPPL-14 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #091249
Mycophenolate Mofetil Tablet; Oral SUPPL-16 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #200197
Mycophenolate Mofetil Capsule; Oral SUPPL-11 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #200197
Mycophenolate Mofetil Capsule; Oral SUPPL-11 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #200197
Mycophenolate Mofetil Capsule; Oral SUPPL-13 Alkem Labs Ltd Labeling Approved
Valsartan and Hydrochlorothiazide
ANDA #201662
Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-19 Alembic Pharms Ltd Labeling Approved
Valsartan and Hydrochlorothiazide
ANDA #201662
Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-19 Alembic Pharms Ltd Labeling Approved
Vortioxetine
ANDA #210953
Vortioxetine Unknown ORIG-1 Amneal Pharms Co Tentative Approval

September 18, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Biaxin
NDA #050662
Clarithromycin Tablet; Oral SUPPL-61 Abbvie Labeling Approved
Biaxin
NDA #050698
Clarithromycin For Suspension; Oral SUPPL-41 Abbvie Labeling Approved
Biaxin Xl
NDA #050775
Clarithromycin Tablet, Extended Release; Oral SUPPL-29 Abbvie Labeling Approved
Daptomycin
NDA #209949
Daptomycin Powder; Iv (Infusion) SUPPL-3 Xellia Pharms Aps Labeling Approved
Opdivo
BLA #125554
Nivolumab Injectable; Injection SUPPL-75 Bristol Myers Squibb Labeling Approved

September 17, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Erleada
NDA #210951
Apalutamide Tablet; Oral SUPPL-1 Janssen Biotech Efficacy Approved
Keytruda
BLA #125514
Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-65 Merck Sharp Dohme Efficacy Approved
Lenvima
NDA #206947
Lenvatinib Mesylate Capsule; Oral SUPPL-11 Eisai Inc Efficacy Approved
Pantoprazole Sodium
ANDA #205675
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #205675
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-5 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #205675
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #205675
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-8 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #205675
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-11 Aurobindo Pharma Ltd Labeling Approved
Tacrolimus
ANDA #065461
Tacrolimus Capsule; Oral SUPPL-32 Sandoz Labeling Approved
Tacrolimus
ANDA #065461
Tacrolimus Capsule; Oral SUPPL-32 Sandoz Labeling Approved
Thalitone
NDA #019574
Chlorthalidone Tablet; Oral SUPPL-17 Casper Pharma Llc Labeling Approved

September 16, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cleocin
NDA #050767
Clindamycin Phosphate Suppository; Vaginal SUPPL-16 Pharmacia and Upjohn Labeling Approved
Ezetimibe and Simvastatin
ANDA #202968
Ezetimibe; Simvastatin Tablet; Oral SUPPL-2 Watson Labs Inc Labeling Approved
Ezetimibe and Simvastatin
ANDA #202968
Ezetimibe; Simvastatin Tablet; Oral SUPPL-3 Watson Labs Inc Labeling Approved
Ezetimibe and Simvastatin
ANDA #202968
Ezetimibe; Simvastatin Tablet; Oral SUPPL-2 Watson Labs Inc Labeling Approved
Ezetimibe and Simvastatin
ANDA #202968
Ezetimibe; Simvastatin Tablet; Oral SUPPL-3 Watson Labs Inc Labeling Approved
Onpattro
NDA #210922
Patisiran Sodium Solution; Intravenous SUPPL-4 Alnylam Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090296
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-2 Sandoz Inc Labeling Approved
Pantoprazole Sodium
ANDA #090296
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-3 Sandoz Inc Labeling Approved
Pantoprazole Sodium
ANDA #090296
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-5 Sandoz Inc Labeling Approved
Pantoprazole Sodium
ANDA #090296
Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-6 Sandoz Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-17 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-14 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-17 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #090970
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Mylan Pharms Inc Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-7 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-2 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-3 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-4 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-7 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-2 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-3 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-4 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-5 Amneal Pharms Labeling Approved
Pantoprazole Sodium
ANDA #205119
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-7 Amneal Pharms Labeling Approved

September 15, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Mesna
ANDA #075811
Mesna Injectable; Intravenous SUPPL-14 Fresenius Kabi Usa Labeling Approved

September 13, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Anastrozole
ANDA #091051
Anastrozole Tablet; Oral SUPPL-7 Mylan Labeling Approved
Anastrozole
ANDA #091051
Anastrozole Tablet; Oral SUPPL-7 Mylan Labeling Approved
Benlysta
BLA #125370
Belimumab Injectable; Injection SUPPL-67 Human Genome Sciences Inc. Labeling Approved
Benlysta
BLA #761043
Belimumab Injectable; Injection SUPPL-5 Glaxosmithkline Llc Labeling Approved
Cyltezo
BLA #761058
Adalimumab-Adbm Injectable; Injection SUPPL-3 Boehringer Ingelheim Labeling Approved
Dolutegravir Sodium
ANDA #212179
Dolutegravir Sodium Unknown ORIG-1 Micro Labs Ltd Tentative Approval
Ivermectin
ANDA #210019
Ivermectin Cream; Topical ORIG-1 Teva Pharms Usa Inc Approved
Levocetirizine Dihydrochloride
ANDA #205564
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-5 Macleods Pharms Ltd Labeling Approved
Levocetirizine Dihydrochloride
ANDA #205564
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-10 Macleods Pharms Ltd Labeling Approved
Levocetirizine Dihydrochloride
ANDA #205564
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-13 Macleods Pharms Ltd Labeling Approved
Mydayis
NDA #022063
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-1 Shire Dev Llc Efficacy Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-8 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-10 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-8 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-10 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Macleods Pharms Ltd Labeling Approved
Pantoprazole Sodium
ANDA #200821
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Macleods Pharms Ltd Labeling Approved
Teflaro
NDA #200327
Ceftaroline Fosamil Powder; Intravenous SUPPL-22 Allergan Sales Llc Efficacy Approved
Tranexamic Acid
ANDA #202436
Tranexamic Acid Injectable; Injection SUPPL-3 Acic Pharms Labeling Approved
Valsartan
ANDA #091367
Valsartan Tablet; Oral SUPPL-5 Alembic Pharms Ltd Labeling Approved
Valsartan
ANDA #091367
Valsartan Tablet; Oral SUPPL-11 Alembic Pharms Ltd Labeling Approved
Valsartan
ANDA #091367
Valsartan Tablet; Oral SUPPL-11 Alembic Pharms Ltd Labeling Approved
Zulresso
NDA #211371
Brexanolone Solution; Intravenous SUPPL-2 Sage Therap Labeling Approved

September 12, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-2 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-2 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-4 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-5 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-2 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-3 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-4 Amneal Pharms Labeling Approved
Clopidogrel Bisulfate
ANDA #203751
Clopidogrel Bisulfate Tablet; Oral SUPPL-5 Amneal Pharms Labeling Approved
Ditropan Xl
NDA #020897
Oxybutynin Chloride Tablet, Extended Release; Oral SUPPL-37 Janssen Pharms Labeling Approved
Ibsrela
NDA #211801
Tenapanor Tablet; Oral ORIG-1 Ardelyx Inc Type 1 - New Molecular Entity Approved
Nucala
BLA #125526
Mepolizumab Injectable; Subcutaneous Lyophilized Power SUPPL-12 Glaxosmithkline Llc Efficacy Approved
Nucala
BLA #761122
Mepolizumab Injectable; Subcutaneous SUPPL-3 Glaxosmithkline Efficacy Approved
Nucala
BLA #761122
Mepolizumab Injectable; Subcutaneous SUPPL-2 Glaxosmithkline Labeling Approved
Nucala
BLA #761122
Mepolizumab Injectable; Subcutaneous SUPPL-2 Glaxosmithkline Labeling Approved
Sabril
NDA #020427
Vigabatrin Tablet; Oral SUPPL-22 Lundbeck Pharms Llc REMS Approved
Sabril
NDA #022006
Vigabatrin For Solution; Oral SUPPL-24 Lundbeck Pharms Llc REMS Approved
Vigabatrin
ANDA #208218
Vigabatrin For Solution; Oral SUPPL-7 Par Pharm Inc REMS Approved
Vigabatrin
ANDA #209822
Vigabatrin Tablet; Oral SUPPL-4 Teva Pharms Usa REMS Approved
Vigabatrin
ANDA #209824
Vigabatrin For Solution; Oral SUPPL-5 Teva Pharms Usa REMS Approved
Vigabatrin
ANDA #210155
Vigabatrin For Solution; Oral SUPPL-4 Amneal Pharms REMS Approved
Vigabatrin
ANDA #211481
Vigabatrin For Solution; Oral SUPPL-2 Dr Reddys Labs Ltd REMS Approved
Vigadrone
ANDA #210196
Vigabatrin For Solution; Oral SUPPL-3 Aucta REMS Approved

September 11, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amantadine Hydrochloride
ANDA #071293
Amantadine Hydrochloride Capsule; Oral SUPPL-40 Sandoz Manufacturing (CMC) Approved
Amantadine Hydrochloride
ANDA #071293
Amantadine Hydrochloride Capsule; Oral SUPPL-38 Sandoz Labeling Approved
Dapagliflozin
ANDA #211482
Dapagliflozin Unknown ORIG-1 Ajanta Pharma Ltd Tentative Approval
Dolutegavir; Lamivudine; Tenofovir Alafenamide Fumarate
NDA #210865
Dolutegavir;Lamivudine;Tenofovir Alafenamide Fumarate Unknown ORIG-1 Mylan Labs Ltd Type 4 - New Combination Tentative Approval
Famotidine
ANDA #206531
Famotidine Tablet; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Famotidine
ANDA #206531
Famotidine Tablet; Oral SUPPL-7 Aurobindo Pharma Ltd Labeling Approved
Famotidine
ANDA #206531
Famotidine Tablet; Oral SUPPL-7 Aurobindo Pharma Ltd Labeling Approved
Indomethacin
ANDA #073314
Indomethacin Suppository; Rectal SUPPL-22 Acp Nimble Labeling Approved
Indomethacin
ANDA #073314
Indomethacin Suppository; Rectal SUPPL-22 Acp Nimble Labeling Approved
Indomethacin
ANDA #073314
Indomethacin Suppository; Rectal SUPPL-23 Acp Nimble Labeling Approved
Mycophenolate Mofetil
ANDA #065379
Mycophenolate Mofetil Capsule; Oral SUPPL-22 Sandoz Labeling Approved
Mycophenolate Mofetil
ANDA #065379
Mycophenolate Mofetil Capsule; Oral SUPPL-22 Sandoz Labeling Approved
Mycophenolate Mofetil
ANDA #065379
Mycophenolate Mofetil Capsule; Oral SUPPL-24 Sandoz Labeling Approved
Mycophenolate Mofetil
ANDA #065416
Mycophenolate Mofetil Tablet; Oral SUPPL-16 Accord Hlthcare Labeling Approved
Mycophenolate Mofetil
ANDA #065451
Mycophenolate Mofetil Tablet; Oral SUPPL-22 Sandoz Labeling Approved
Mycophenolate Mofetil
ANDA #065451
Mycophenolate Mofetil Tablet; Oral SUPPL-25 Sandoz Labeling Approved
Mycophenolate Mofetil
ANDA #065520
Mycophenolate Mofetil Capsule; Oral SUPPL-20 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #065520
Mycophenolate Mofetil Capsule; Oral SUPPL-22 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #065520
Mycophenolate Mofetil Capsule; Oral SUPPL-20 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #065520
Mycophenolate Mofetil Capsule; Oral SUPPL-22 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #065521
Mycophenolate Mofetil Tablet; Oral SUPPL-20 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #065521
Mycophenolate Mofetil Tablet; Oral SUPPL-18 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #065521
Mycophenolate Mofetil Tablet; Oral SUPPL-20 Mylan Labeling Approved
Mycophenolate Mofetil
ANDA #090253
Mycophenolate Mofetil Capsule; Oral SUPPL-16 Accord Hlthcare Labeling Approved
Oxaprozin
ANDA #075855
Oxaprozin Tablet; Oral SUPPL-8 Dr Reddys Labs Ltd Labeling Approved
Oxaprozin
ANDA #075855
Oxaprozin Tablet; Oral SUPPL-9 Dr Reddys Labs Ltd Labeling Approved
Oxaprozin
ANDA #075855
Oxaprozin Tablet; Oral SUPPL-8 Dr Reddys Labs Ltd Labeling Approved
Oxaprozin
ANDA #075855
Oxaprozin Tablet; Oral SUPPL-9 Dr Reddys Labs Ltd Labeling Approved
Paxil Cr
NDA #020936
Paroxetine Hydrochloride Tablet, Extended Release; Oral SUPPL-47 Apotex Technologies Labeling Approved

September 10, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aczone
NDA #207154
Dapsone Gel; Topical SUPPL-4 Almirall Efficacy Approved
Aczone
NDA #207154
Dapsone Gel; Topical SUPPL-4 Almirall Efficacy Approved
Altabax
NDA #022055
Retapamulin Ointment; Topical SUPPL-7 Almirall Labeling Approved
Apixaban
ANDA #209944
Apixaban Tablet; Oral ORIG-1 Sunshine Lake Tentative Approval
Gvoke
NDA #212097
Glucagon Injectable; Injection ORIG-1 Xeris Pharma Inc Type 3 - New Dosage Form Approved
Mycophenolate Mofetil
ANDA #065491
Mycophenolate Mofetil Capsule; Oral SUPPL-17 Teva Pharms Labeling Approved
Mycophenolate Mofetil
ANDA #065491
Mycophenolate Mofetil Capsule; Oral SUPPL-18 Teva Pharms Labeling Approved
Mycophenolate Mofetil
ANDA #065491
Mycophenolate Mofetil Capsule; Oral SUPPL-17 Teva Pharms Labeling Approved
Mycophenolate Mofetil
ANDA #065491
Mycophenolate Mofetil Capsule; Oral SUPPL-18 Teva Pharms Labeling Approved
Mycophenolate Mofetil
ANDA #091249
Mycophenolate Mofetil Tablet; Oral SUPPL-14 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #091249
Mycophenolate Mofetil Tablet; Oral SUPPL-14 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #091249
Mycophenolate Mofetil Tablet; Oral SUPPL-16 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #200197
Mycophenolate Mofetil Capsule; Oral SUPPL-11 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #200197
Mycophenolate Mofetil Capsule; Oral SUPPL-11 Alkem Labs Ltd Labeling Approved
Mycophenolate Mofetil
ANDA #200197
Mycophenolate Mofetil Capsule; Oral SUPPL-13 Alkem Labs Ltd Labeling Approved
Valsartan and Hydrochlorothiazide
ANDA #201662
Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-19 Alembic Pharms Ltd Labeling Approved
Valsartan and Hydrochlorothiazide
ANDA #201662
Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-19 Alembic Pharms Ltd Labeling Approved
Vortioxetine
ANDA #210953
Vortioxetine Unknown ORIG-1 Amneal Pharms Co Tentative Approval

September 9, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azacitidine
ANDA #201537
Azacitidine Powder; Intravenous, Subcutaneous SUPPL-8 Dr Reddys Labeling Approved
Celecoxib
ANDA #206827
Celecoxib Capsule; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Celecoxib
ANDA #206827
Celecoxib Capsule; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Clindamycin Phosphate and Benzoyl Peroxide
ANDA #205397
Benzoyl Peroxide; Clindamycin Phosphate Gel; Topical ORIG-1 Perrigo Israel Approved
Glucagon
NDA #201849
Glucagon Hydrochloride Powder; Intramuscular, Intravenous SUPPL-5 Fresenius Kabi Usa Efficacy Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #203863
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-2 Epic Pharma Llc Labeling Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #203863
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-2 Epic Pharma Llc Labeling Approved
Ibrance
NDA #207103
Palbociclib Capsule; Oral SUPPL-11 Pfizer Inc Efficacy Approved
Ibrance
NDA #207103
Palbociclib Capsule; Oral SUPPL-12 Pfizer Inc Labeling Approved
Ibrance
NDA #207103
Palbociclib Capsule; Oral SUPPL-12 Pfizer Inc Labeling Approved
Kisqali
NDA #209092
Ribociclib Succinate Tablet; Oral SUPPL-4 Novartis Pharms Corp Labeling Approved
Kisqali Femara Co-Pack (Copackaged)
NDA #209935
Letrozole; Ribociclib Succinate Tablet, Tablet; Oral SUPPL-7 Novartis Pharms Corp Labeling Approved
Mibelas 24 Fe
ANDA #206287
Ethinyl Estradiol; Norethindrone Acetate Tablet, Chewable; Oral SUPPL-1 Lupin Atlantis Labeling Approved
Mibelas 24 Fe
ANDA #206287
Ethinyl Estradiol; Norethindrone Acetate Tablet, Chewable; Oral SUPPL-8 Lupin Atlantis Manufacturing (CMC) Approved
Mibelas 24 Fe
ANDA #206287
Ethinyl Estradiol; Norethindrone Acetate Tablet, Chewable; Oral SUPPL-8 Lupin Atlantis Manufacturing (CMC) Approved
Mibelas 24 Fe
ANDA #206287
Ethinyl Estradiol; Norethindrone Acetate Tablet, Chewable; Oral SUPPL-1 Lupin Atlantis Labeling Approved
Mibelas 24 Fe
ANDA #206287
Ethinyl Estradiol; Norethindrone Acetate Tablet, Chewable; Oral SUPPL-6 Lupin Atlantis Labeling Approved
Mibelas 24 Fe
ANDA #206287
Ethinyl Estradiol; Norethindrone Acetate Tablet, Chewable; Oral SUPPL-8 Lupin Atlantis Manufacturing (CMC) Approved
Mibelas 24 Fe
ANDA #206287
Ethinyl Estradiol; Norethindrone Acetate Tablet, Chewable; Oral SUPPL-8 Lupin Atlantis Manufacturing (CMC) Approved
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
ANDA #078267
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-9 Amneal Pharms Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
ANDA #078267
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-9 Amneal Pharms Labeling Approved
Oxybutynin Chloride
ANDA #078503
Oxybutynin Chloride Tablet, Extended Release; Oral SUPPL-7 Osmotica Pharm Us Labeling Approved
Oxybutynin Chloride
ANDA #078503
Oxybutynin Chloride Tablet, Extended Release; Oral SUPPL-9 Osmotica Pharm Us Labeling Approved
Pravastatin Sodium
ANDA #076397
Pravastatin Sodium Tablet; Oral SUPPL-7 Apnar Pharma Lp Labeling Approved
Pravastatin Sodium
ANDA #077491
Pravastatin Sodium Tablet; Oral SUPPL-5 Apnar Pharma Lp Labeling Approved
Prochlorperazine Edisylate
ANDA #204147
Prochlorperazine Edisylate Injectable; Injection SUPPL-21 Emcure Pharms Ltd Manufacturing (CMC) Approved
Prochlorperazine Edisylate
ANDA #204147
Prochlorperazine Edisylate Injectable; Injection SUPPL-21 Emcure Pharms Ltd Manufacturing (CMC) Approved
Raloxifene Hydrochloride
ANDA #078193
Raloxifene Hydrochloride Tablet; Oral SUPPL-5 Teva Pharms Usa Labeling Approved
Raloxifene Hydrochloride
ANDA #078193
Raloxifene Hydrochloride Tablet; Oral SUPPL-8 Teva Pharms Usa Labeling Approved
Raloxifene Hydrochloride
ANDA #078193
Raloxifene Hydrochloride Tablet; Oral SUPPL-5 Teva Pharms Usa Labeling Approved
Raloxifene Hydrochloride
ANDA #078193
Raloxifene Hydrochloride Tablet; Oral SUPPL-8 Teva Pharms Usa Labeling Approved
Sivextro
NDA #205435
Tedizolid Phosphate Tablet; Oral SUPPL-11 Cubist Pharms Llc Labeling Approved
Sivextro
NDA #205436
Tedizolid Phosphate Powder; Intravenous SUPPL-6 Cubist Pharms Llc Labeling Approved
Tamsulosin Hydrochloride
ANDA #078225
Tamsulosin Hydrochloride Capsule; Oral SUPPL-14 Zydus Pharms Usa Inc Labeling Approved
Tamsulosin Hydrochloride
ANDA #078225
Tamsulosin Hydrochloride Capsule; Oral SUPPL-14 Zydus Pharms Usa Inc Labeling Approved
Tamsulosin Hydrochloride
ANDA #090931
Tamsulosin Hydrochloride Capsule; Oral SUPPL-10 Sun Pharm Inds Ltd Labeling Approved
Tamsulosin Hydrochloride
ANDA #090931
Tamsulosin Hydrochloride Capsule; Oral SUPPL-10 Sun Pharm Inds Ltd Labeling Approved
Tamsulosin Hydrochloride
ANDA #202433
Tamsulosin Hydrochloride Capsule; Oral SUPPL-12 Aurobindo Pharma Ltd Labeling Approved
Telmisartan and Amlodipine
ANDA #202516
Amlodipine Besylate; Telmisartan Tablet; Oral SUPPL-4 Mylan Labeling Approved
Telmisartan and Amlodipine
ANDA #202516
Amlodipine Besylate; Telmisartan Tablet; Oral SUPPL-6 Mylan Labeling Approved
Telmisartan and Amlodipine
ANDA #202516
Amlodipine Besylate; Telmisartan Tablet; Oral SUPPL-6 Mylan Labeling Approved
Tramadol Hydrochloride
ANDA #201384
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Sun Pharm Labeling Approved
Tramadol Hydrochloride
ANDA #201384
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Sun Pharm Labeling Approved
Verzenio
NDA #208716
Abemaciclib Tablet; Oral SUPPL-3 Eli Lilly and Co Labeling Approved
Verzenio
NDA #208716
Abemaciclib Tablet; Oral SUPPL-3 Eli Lilly and Co Labeling Approved

September 6, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Advil Allergy and Congestion Relief
NDA #022113
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride Tablet; Oral SUPPL-8 Pfizer Labeling Approved
Advil Multi-Symptom Cold & Flu
NDA #022113
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride Tablet; Oral SUPPL-8 Pfizer Labeling Approved
Aubagio
NDA #202992
Teriflunomide Tablet; Oral SUPPL-8 Sanofi Aventis Us Labeling Approved
Aubagio
NDA #202992
Teriflunomide Tablet; Oral SUPPL-8 Sanofi Aventis Us Labeling Approved
Cimzia
BLA #125160
Certolizumab Pegol Injectable; Injection SUPPL-293 Ucb Inc Labeling Approved
Clobetasol Propionate
ANDA #074248
Clobetasol Propionate Ointment; Topical SUPPL-24 Taro Labeling Approved
Clobetasol Propionate
ANDA #075279
Clobetasol Propionate Gel; Topical SUPPL-13 Taro Labeling Approved
Clobetasol Propionate
ANDA #075391
Clobetasol Propionate Solution; Topical SUPPL-12 Fougera Pharms Labeling Approved
Clobetasol Propionate
ANDA #076977
Clobetasol Propionate Solution; Topical SUPPL-11 Tolmar Labeling Approved
Clobetasol Propionate
ANDA #090898
Clobetasol Propionate Spray; Topical SUPPL-4 Paddock Llc Labeling Approved
Clobetasol Propionate
ANDA #090898
Clobetasol Propionate Spray; Topical SUPPL-6 Paddock Llc Labeling Approved
Clobetasol Propionate
ANDA #090974
Clobetasol Propionate Shampoo; Topical SUPPL-5 Perrigo Israel Labeling Approved
Clobetasol Propionate
ANDA #200302
Clobetasol Propionate Lotion; Topical SUPPL-2 Taro Labeling Approved
Clobetasol Propionate
ANDA #201402
Clobetasol Propionate Aerosol, Foam; Topical SUPPL-2 Perrigo Uk Finco Labeling Approved
Clobetasol Propionate
ANDA #201402
Clobetasol Propionate Aerosol, Foam; Topical SUPPL-13 Perrigo Uk Finco Labeling Approved
Clobetasol Propionate
ANDA #206378
Clobetasol Propionate Spray; Topical SUPPL-3 Zydus Pharms Labeling Approved
Clobetasol Propionate
ANDA #206805
Clobetasol Propionate Aerosol, Foam; Topical SUPPL-1 Ingenus Pharms Llc Labeling Approved
Clobetasol Propionate
ANDA #206805
Clobetasol Propionate Aerosol, Foam; Topical SUPPL-1 Ingenus Pharms Llc Labeling Approved
Clobetasol Propionate
ANDA #208125
Clobetasol Propionate Spray; Topical SUPPL-1 Lupin Ltd Labeling Approved
Clobetasol Propionate
ANDA #208667
Clobetasol Propionate Lotion; Topical SUPPL-1 Teligent Pharma Inc Labeling Approved
Docetaxel
ANDA #207563
Docetaxel Injectable; Injection SUPPL-2 Ingenus Pharms Llc Labeling Approved
Docetaxel
ANDA #207563
Docetaxel Injectable; Injection SUPPL-4 Ingenus Pharms Llc Labeling Approved
Meropenem
ANDA #204139
Meropenem Injectable; Injection SUPPL-1 Acs Dobfar Spa Labeling Approved
Mesna
ANDA #075764
Mesna Injectable; Intravenous SUPPL-28 Teva Pharms Usa Labeling Approved
Mesna
ANDA #075764
Mesna Injectable; Intravenous SUPPL-28 Teva Pharms Usa Labeling Approved
Mesna
ANDA #206992
Mesna Injectable; Intravenous SUPPL-1 Gland Pharma Ltd Labeling Approved
Mesna
ANDA #206992
Mesna Injectable; Intravenous SUPPL-3 Gland Pharma Ltd Labeling Approved
Ofev
NDA #205832
Nintedanib Esylate Capsule; Oral SUPPL-12 Boehringer Ingelheim Efficacy Approved
Pulmicort Flexhaler
NDA #021949
Budesonide Powder, Metered; Inhalation SUPPL-13 Astrazeneca Labeling Approved
Pulmicort Respules
NDA #020929
Budesonide Suspension; Inhalation SUPPL-52 Astrazeneca Pharms Labeling Approved
Temazepam
ANDA #071427
Temazepam Capsule; Oral SUPPL-30 Sandoz Labeling Approved
Temazepam
ANDA #071427
Temazepam Capsule; Oral SUPPL-31 Sandoz Labeling Approved
Temazepam
ANDA #071427
Temazepam Capsule; Oral SUPPL-30 Sandoz Labeling Approved
Temazepam
ANDA #071427
Temazepam Capsule; Oral SUPPL-31 Sandoz Labeling Approved
Temazepam
ANDA #071428
Temazepam Capsule; Oral SUPPL-30 Sandoz Labeling Approved
Temazepam
ANDA #071428
Temazepam Capsule; Oral SUPPL-30 Sandoz Labeling Approved
Temazepam
ANDA #071428
Temazepam Capsule; Oral SUPPL-31 Sandoz Labeling Approved
Temazepam
ANDA #071428
Temazepam Capsule; Oral SUPPL-30 Sandoz Labeling Approved
Temazepam
ANDA #071428
Temazepam Capsule; Oral SUPPL-31 Sandoz Labeling Approved
Valsartan and Hydrochlorothiazide
ANDA #078020
Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-13 Mylan Pharms Inc Labeling Approved
Valsartan and Hydrochlorothiazide
ANDA #078020
Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-13 Mylan Pharms Inc Labeling Approved
Vivitrol
NDA #021897
Naltrexone For Suspension, Extended Release; Intramuscular SUPPL-45 Alkermes Labeling Approved
Vivitrol
NDA #021897
Naltrexone For Suspension, Extended Release; Intramuscular SUPPL-45 Alkermes Labeling Approved
Vivitrol
NDA #021897
Naltrexone For Suspension, Extended Release; Intramuscular SUPPL-45 Alkermes Labeling Approved

September 5, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Anastrozole
ANDA #078921
Anastrozole Tablet; Oral SUPPL-8 Zydus Pharms Usa Inc Labeling Approved
Anastrozole
ANDA #078921
Anastrozole Tablet; Oral SUPPL-8 Zydus Pharms Usa Inc Labeling Approved
Asparlas
BLA #761102
Calaspargase Pegol-Mknl Injectable; Intravenous SUPPL-2 Servier Pharma Llc Labeling Approved
Busulfan
ANDA #205184
Busulfan Injectable; Injection SUPPL-1 Mylan Labs Ltd Labeling Approved
Caspofungin Acetate
ANDA #207092
Caspofungin Acetate Powder; Intravenous SUPPL-1 Gland Pharma Ltd Labeling Approved
Caspofungin Acetate
ANDA #207092
Caspofungin Acetate Powder; Intravenous SUPPL-3 Gland Pharma Ltd Labeling Approved
Clinda-Derm
ANDA #063329
Clindamycin Phosphate Solution; Topical SUPPL-6 Paddock Llc Labeling Approved
Docetaxel
ANDA #208859
Docetaxel Injectable; Injection SUPPL-2 Mylan Labs Ltd Labeling Approved
Docetaxel
ANDA #210072
Docetaxel Injectable; Injection SUPPL-3 Mylan Labs Ltd Labeling Approved
Docetaxel
ANDA #210848
Docetaxel Injectable; Injection SUPPL-2 Mylan Labs Ltd Labeling Approved
Donepezil Hydrochloride
ANDA #202410
Donepezil Hydrochloride Tablet; Oral SUPPL-1 Hisun Pharm Hangzhou Labeling Approved
Donepezil Hydrochloride
ANDA #202410
Donepezil Hydrochloride Tablet; Oral SUPPL-1 Hisun Pharm Hangzhou Labeling Approved
Donepezil Hydrochloride
ANDA #202656
Donepezil Hydrochloride Tablet; Oral SUPPL-2 Mylan Labeling Approved
Donepezil Hydrochloride
ANDA #202656
Donepezil Hydrochloride Tablet; Oral SUPPL-2 Mylan Labeling Approved
Doxycycline Hyclate
ANDA #207289
Doxycycline Hyclate Capsule; Oral SUPPL-3 Amneal Pharms Labeling Approved
Doxycycline Hyclate
ANDA #207289
Doxycycline Hyclate Capsule; Oral SUPPL-1 Amneal Pharms Labeling Approved
Doxycycline Hyclate
ANDA #207289
Doxycycline Hyclate Capsule; Oral SUPPL-3 Amneal Pharms Labeling Approved
Doxycycline Hyclate
ANDA #207289
Doxycycline Hyclate Capsule; Oral SUPPL-6 Amneal Pharms Labeling Approved
Doxycycline Hyclate
ANDA #207774
Doxycycline Hyclate Capsule; Oral SUPPL-1 Zydus Pharms Labeling Approved
Doxycycline Hyclate
ANDA #207774
Doxycycline Hyclate Capsule; Oral SUPPL-1 Zydus Pharms Labeling Approved
Doxycycline Hyclate
ANDA #211012
Doxycycline Hyclate Capsule; Oral SUPPL-1 Ajanta Pharma Ltd Labeling Approved
Fosaprepitant
NDA #210064
Fosaprepitant Injectable; Injection ORIG-1 Teva Pharms Usa Inc Type 5 - New Formulation or New Manufacturer Approved
Fosaprepitant Dimeglumine
ANDA #205020
Fosaprepitant Dimeglumine Powder; Intravenous ORIG-1 Apotex Inc Approved
Fosaprepitant Dimeglumine
ANDA #209965
Fosaprepitant Dimeglumine Powder; Intravenous ORIG-1 Msn Labs Pvt Ltd Approved
Fosaprepitant Dimeglumine
ANDA #210689
Fosaprepitant Dimeglumine Powder; Intravenous ORIG-1 Lupin Ltd Approved
Metformin Hydrochloride
ANDA #091664
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-2 Lupin Ltd Labeling Approved
Metformin Hydrochloride
ANDA #091664
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-6 Lupin Ltd Labeling Approved
Metformin Hydrochloride
ANDA #091664
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-6 Lupin Ltd Labeling Approved
Methylprednisolone
ANDA #040183
Methylprednisolone Tablet; Oral SUPPL-18 Vintage Pharms Labeling Approved
Octreotide Acetate (Preservative Free)
ANDA #079198
Octreotide Acetate Injectable; Injection SUPPL-7 Mylan Institutional Labeling Approved
Paragard T 380a
NDA #018680
Copper Intrauterine Device; Intrauterine SUPPL-70 Coopersurgical Labeling Approved
Paragard T 380a
NDA #018680
Copper Intrauterine Device; Intrauterine SUPPL-69 Coopersurgical Labeling Approved
Remeron
NDA #020415
Mirtazapine Tablet; Oral SUPPL-35 Organon Usa Inc Labeling Approved
Remeron Soltab
NDA #021208
Mirtazapine Tablet, Orally Disintegrating; Oral SUPPL-25 Organon Usa Inc Labeling Approved
Sulfamethoxazole and Trimethoprim
NDA #018598
Sulfamethoxazole; Trimethoprim Tablet; Oral SUPPL-52 Fosun Pharma Labeling Approved
Sulfamethoxazole and Trimethoprim Double Strength
NDA #018598
Sulfamethoxazole; Trimethoprim Tablet; Oral SUPPL-52 Fosun Pharma Labeling Approved
Valsartan and Hydrochlorothiazide
ANDA #078946
Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-7 Lupin Ltd Labeling Approved
Valsartan and Hydrochlorothiazide
ANDA #078946
Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-6 Lupin Ltd Labeling Approved
Valsartan and Hydrochlorothiazide
ANDA #078946
Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-7 Lupin Ltd Labeling Approved
Valsartan and Hydrochlorothiazide
ANDA #078946
Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-6 Lupin Ltd Labeling Approved
Valsartan and Hydrochlorothiazide
ANDA #078946
Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-7 Lupin Ltd Labeling Approved

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