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.

November 21, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Calquence
NDA #210259
Acalabrutinib Capsule; Oral SUPPL-6 Astrazeneca Efficacy Approved
Calquence
NDA #210259
Acalabrutinib Capsule; Oral SUPPL-7 Astrazeneca Efficacy Approved

November 20, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cayston
NDA #050814
Aztreonam For Solution; Inhalation SUPPL-23 Gilead Labeling Approved
Deferasirox
ANDA #209782
Deferasirox Tablet, For Suspension; Oral ORIG-1 Sun Pharm Approved
Deferasirox
ANDA #209878
Deferasirox Tablet, For Suspension; Oral ORIG-1 Msn Labs Pvt Ltd Approved
Deferasirox
ANDA #210060
Deferasirox Tablet, For Suspension; Oral ORIG-1 Alembic Pharms Ltd Approved
Deferasirox
ANDA #210519
Deferasirox Tablet, For Suspension; Oral ORIG-1 Alkem Labs Ltd Approved
Deferasirox
ANDA #210920
Deferasirox Tablet, For Suspension; Oral ORIG-1 Bionpharma Inc Approved
Deferasirox
ANDA #210945
Deferasirox Tablet; Oral ORIG-1 Msn Labs Pvt Ltd Approved
Deferasirox
ANDA #210945
Deferasirox Tablet; Oral ORIG-2 Msn Labs Pvt Ltd Tentative Approval
Desonide
ANDA #210198
Desonide Cream; Topical ORIG-1 Zydus Pharms Approved
Fosamprenavir Calcium
ANDA #204024
Fosamprenavir Calcium Tablet; Oral ORIG-1 Sun Pharm Approved
Givlaari
NDA #212194
Givosiran Injectable; Injection ORIG-1 Alnylam Pharms Inc Type 1 - New Molecular Entity Approved
Lamotrigine
ANDA #077420
Lamotrigine Tablet; Oral SUPPL-17 Mylan Labeling Approved
Lamotrigine
ANDA #077420
Lamotrigine Tablet; Oral SUPPL-18 Mylan Labeling Approved
Lamotrigine
ANDA #077420
Lamotrigine Tablet; Oral SUPPL-17 Mylan Labeling Approved
Lamotrigine
ANDA #077420
Lamotrigine Tablet; Oral SUPPL-18 Mylan Labeling Approved
Mesalamine
ANDA #207271
Mesalamine Capsule, Extended Release; Oral ORIG-1 Mylan Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-1 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-2 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-3 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-4 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-1 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-2 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-3 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-4 Apotex Labeling Approved

November 19, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Focalin
NDA #021278
Dexmethylphenidate Hydrochloride Tablet; Oral SUPPL-26 Novartis Labeling Approved
Focalin Xr
NDA #021802
Dexmethylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-36 Novartis Labeling Approved
Ivermectin
ANDA #212485
Ivermectin Unknown ORIG-1 Teva Pharms Usa Tentative Approval
Ritalin
NDA #010187
Methylphenidate Hydrochloride Tablet; Oral SUPPL-91 Novartis Labeling Approved
Ritalin La
NDA #021284
Methylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-41 Novartis Labeling Approved
Ritalin-Sr
NDA #018029
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-59 Novartis Labeling Approved
Tavaborole
ANDA #212215
Tavaborole Unknown ORIG-1 Taro Pharma Usa Inc Tentative Approval
Tenofovir Disoproxil Fumarate
ANDA #078800
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-18 Cipla Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #078800
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-17 Cipla Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #078800
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-18 Cipla Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #078800
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-19 Cipla Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #078800
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-20 Cipla Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #090742
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-12 Strides Pharma Labeling Approved
Turalio
NDA #211810
Pexidartinib Hydrochloride Capsule; Oral SUPPL-1 Daiichi Sankyo Inc REMS Approved
Turalio
NDA #211810
Pexidartinib Hydrochloride Capsule; Oral SUPPL-2 Daiichi Sankyo Inc REMS Approved
Xyosted (Autoinjector)
NDA #209863
Testosterone Enanthate Solution; Subcutaneous SUPPL-2 Antares Pharma Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-15 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-16 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-17 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-18 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-15 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-16 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-17 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-18 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #078148
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-11 Anchen Pharms Labeling Approved
Zolpidem Tartrate
ANDA #078148
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-12 Anchen Pharms Labeling Approved
Zolpidem Tartrate
ANDA #078148
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-13 Anchen Pharms Labeling Approved
Zolpidem Tartrate
ANDA #078148
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-15 Anchen Pharms Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-14 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-15 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-16 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-14 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-15 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-16 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-15 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-6 Sandoz Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-8 Sandoz Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-9 Sandoz Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-6 Sandoz Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-7 Sandoz Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-8 Sandoz Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-9 Sandoz Labeling Approved

November 18, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amlodipine Besylate and Atorvastatin Calcium
ANDA #205199
Amlodipine Besylate; Atorvastatin Calcium Tablet; Oral ORIG-1 Apotex Approved
Ampicillin Sodium
ANDA #090581
Ampicillin Sodium Injectable; Injection SUPPL-3 Sagent Pharms Inc Labeling Approved
Diltiazem Hydrochloride
ANDA #211596
Diltiazem Hydrochloride Tablet; Oral ORIG-1 Edenbridge Pharms Approved
Ecoza
NDA #205175
Econazole Nitrate Aerosol, Foam; Topical SUPPL-3 Glenmark Labeling Approved
Irinotecan Hydrochloride
ANDA #212993
Irinotecan Hydrochloride Injectable; Injection ORIG-1 Gland Pharma Ltd Approved
Nystatin and Triamcinolone Acetonide
ANDA #207316
Nystatin; Triamcinolone Acetonide Ointment; Topical ORIG-1 Vitruvias Therap Approved
Tacrolimus
ANDA #090802
Tacrolimus Capsule; Oral SUPPL-7 Panacea Biotec Ltd Labeling Approved
Tylenol W/ Codeine No. 1
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-63 Janssen Pharms Labeling Approved
Tylenol W/ Codeine No. 2
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-63 Janssen Pharms Labeling Approved
Tylenol W/ Codeine No. 3
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-63 Janssen Pharms Labeling Approved
Tylenol W/ Codeine No. 4
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-63 Janssen Pharms Labeling Approved

November 16, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ampicillin and Sulbactam
ANDA #065176
Ampicillin Sodium; Sulbactam Sodium Injectable; Injection SUPPL-14 Hanford Gc Labeling Approved
Ampicillin and Sulbactam
ANDA #065188
Ampicillin Sodium; Sulbactam Sodium Injectable; Injection SUPPL-16 Hanford Gc Labeling Approved
Cefuroxime
ANDA #065048
Cefuroxime Injectable; Injection SUPPL-17 Hikma Farmaceutica Labeling Approved
Cefuroxime Sodium
ANDA #065046
Cefuroxime Sodium Injectable; Injection SUPPL-11 Hikma Farmaceutica Labeling Approved
Cefuroxime Sodium
ANDA #065048
Cefuroxime Sodium Injectable; Injection SUPPL-17 Hikma Farmaceutica Labeling Approved
Cefuroxime Sodium
ANDA #065048
Cefuroxime Sodium Injectable; Intramuscular, Intravenous SUPPL-17 Hikma Farmaceutica Labeling Approved

November 15, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Abrilada
BLA #761118
Adalimumab-Afzb Injectable; Injection ORIG-1 Pfizer Inc Type 2 - New Active Ingredient Approved
Adakveo
BLA #761128
Crizanlizumab-Tmca Injectable; Injection ORIG-1 Novartis Pharms Corp Type 1 - New Molecular Entity Approved
Admelog
NDA #209196
Insulin Lispro Solution; Intravenous, Subcutaneous SUPPL-4 Sanofi-Aventis Us Labeling Approved
Admelog
NDA #209196
Insulin Lispro Solution; Intravenous, Subcutaneous SUPPL-5 Sanofi-Aventis Us Labeling Approved
Admelog Solostar
NDA #209196
Insulin Lispro Solution; Intravenous, Subcutaneous SUPPL-4 Sanofi-Aventis Us Labeling Approved
Admelog Solostar
NDA #209196
Insulin Lispro Solution; Intravenous, Subcutaneous SUPPL-5 Sanofi-Aventis Us Labeling Approved
Apidra
NDA #021629
Insulin Glulisine Recombinant Injectable; Intravenous, Subcutaneous SUPPL-39 Sanofi Aventis Us Labeling Approved
Apidra
NDA #021629
Insulin Glulisine Recombinant Injectable; Intravenous, Subcutaneous SUPPL-39 Sanofi Aventis Us Labeling Approved
Apidra
NDA #021629
Insulin Glulisine Recombinant Injectable; Intravenous, Subcutaneous SUPPL-40 Sanofi Aventis Us Labeling Approved
Apidra
NDA #021629
Insulin Glulisine Recombinant Injectable; Intravenous, Subcutaneous SUPPL-40 Sanofi Aventis Us Labeling Approved
Apidra Solostar
NDA #021629
Insulin Glulisine Recombinant Injectable; Subcutaneous SUPPL-39 Sanofi Aventis Us Labeling Approved
Apidra Solostar
NDA #021629
Insulin Glulisine Recombinant Injectable; Subcutaneous SUPPL-39 Sanofi Aventis Us Labeling Approved
Apidra Solostar
NDA #021629
Insulin Glulisine Recombinant Injectable; Subcutaneous SUPPL-40 Sanofi Aventis Us Labeling Approved
Apidra Solostar
NDA #021629
Insulin Glulisine Recombinant Injectable; Subcutaneous SUPPL-40 Sanofi Aventis Us Labeling Approved
Apremilast
ANDA #211859
Apremilast Unknown ORIG-1 Zydus Pharms Usa Inc Tentative Approval
Basaglar
NDA #205692
Insulin Glargine Solution; Subcutaneous SUPPL-21 Eli Lilly and Co Labeling Approved
Basaglar
NDA #205692
Insulin Glargine Solution; Subcutaneous SUPPL-24 Eli Lilly and Co Labeling Approved
Basaglar
NDA #205692
Insulin Glargine Solution; Subcutaneous SUPPL-21 Eli Lilly and Co Labeling Approved
Basaglar
NDA #205692
Insulin Glargine Solution; Subcutaneous SUPPL-24 Eli Lilly and Co Labeling Approved
Basaglar
NDA #205692
Insulin Glargine Solution; Subcutaneous SUPPL-25 Eli Lilly and Co Labeling Approved
Basaglar
NDA #205692
Insulin Glargine Solution; Subcutaneous SUPPL-21 Eli Lilly and Co Labeling Approved
Blisovi 24 Fe
ANDA #091398
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-14 Lupin Ltd Manufacturing (CMC) Approved
Clobetasol Propionate
ANDA #211295
Clobetasol Propionate Ointment; Topical ORIG-1 Encube Approved
Daptomycin
ANDA #207104
Daptomycin Powder; Intravenous ORIG-1 Sagent Pharms Inc Approved
Enskyce
ANDA #201887
Desogestrel; Ethinyl Estradiol Tablet; Oral-28 SUPPL-15 Lupin Ltd Manufacturing (CMC) Approved
Epclusa
NDA #208341
Sofosbuvir; Velpatasvir Tablet; Oral SUPPL-12 Gilead Sciences Inc Efficacy Approved
Fiasp
NDA #208751
Insulin Aspart Solution; Intravenous, Subcutaneous SUPPL-12 Novo Labeling Approved
Fiasp
NDA #208751
Insulin Aspart Solution; Intravenous, Subcutaneous SUPPL-12 Novo Labeling Approved
Fiasp Flextouch
NDA #208751
Insulin Aspart Solution; Subcutaneous SUPPL-12 Novo Labeling Approved
Fiasp Flextouch
NDA #208751
Insulin Aspart Solution; Subcutaneous SUPPL-12 Novo Labeling Approved
Fiasp Penfill
NDA #208751
Insulin Aspart Solution; Subcutaneous SUPPL-12 Novo Labeling Approved
Fiasp Penfill
NDA #208751
Insulin Aspart Solution; Subcutaneous SUPPL-12 Novo Labeling Approved
Harvoni
NDA #205834
Ledipasvir; Sofosbuvir Tablet; Oral SUPPL-28 Gilead Sciences Inc Efficacy Approved
Harvoni
NDA #212477
Ledipasvir; Sofosbuvir Pellets; Oral SUPPL-2 Gilead Sciences Inc Efficacy Approved
Humalog
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-198 Lilly Labeling Approved
Humalog
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-198 Lilly Labeling Approved
Humalog
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-199 Lilly Labeling Approved
Humalog
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog Kwikpen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog Kwikpen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-198 Lilly Labeling Approved
Humalog Kwikpen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog Kwikpen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-198 Lilly Labeling Approved
Humalog Kwikpen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-199 Lilly Labeling Approved
Humalog Kwikpen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog Kwikpen
NDA #205747
Insulin Lispro Recombinant Solution; Subcutaneous SUPPL-22 Eli Lilly and Co Labeling Approved
Humalog Kwikpen
NDA #205747
Insulin Lispro Recombinant Solution; Subcutaneous SUPPL-25 Eli Lilly and Co Labeling Approved
Humalog Kwikpen
NDA #205747
Insulin Lispro Recombinant Solution; Subcutaneous SUPPL-22 Eli Lilly and Co Labeling Approved
Humalog Kwikpen
NDA #205747
Insulin Lispro Recombinant Solution; Subcutaneous SUPPL-26 Eli Lilly and Co Labeling Approved
Humalog Kwikpen
NDA #205747
Insulin Lispro Recombinant Solution; Subcutaneous SUPPL-22 Eli Lilly and Co Labeling Approved
Humalog Mix 50/50
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-127 Lilly Labeling Approved
Humalog Mix 50/50
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-127 Lilly Labeling Approved
Humalog Mix 50/50
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-129 Lilly Labeling Approved
Humalog Mix 50/50 Kwikpen
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-127 Lilly Labeling Approved
Humalog Mix 50/50 Kwikpen
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-127 Lilly Labeling Approved
Humalog Mix 50/50 Kwikpen
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-129 Lilly Labeling Approved
Humalog Mix 50/50 Pen
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-127 Lilly Labeling Approved
Humalog Mix 50/50 Pen
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-127 Lilly Labeling Approved
Humalog Mix 50/50 Pen
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-129 Lilly Labeling Approved
Humalog Mix 75/25
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-141 Lilly Labeling Approved
Humalog Mix 75/25
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-141 Lilly Labeling Approved
Humalog Mix 75/25
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-143 Lilly Labeling Approved
Humalog Mix 75/25 Kwikpen
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-141 Lilly Labeling Approved
Humalog Mix 75/25 Kwikpen
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-141 Lilly Labeling Approved
Humalog Mix 75/25 Kwikpen
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-143 Lilly Labeling Approved
Humalog Mix 75/25 Pen
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-141 Lilly Labeling Approved
Humalog Mix 75/25 Pen
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-141 Lilly Labeling Approved
Humalog Mix 75/25 Pen
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-143 Lilly Labeling Approved
Humalog Pen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog Pen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-198 Lilly Labeling Approved
Humalog Pen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog Pen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-198 Lilly Labeling Approved
Humalog Pen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-199 Lilly Labeling Approved
Humalog Pen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humulin 70/30
NDA #019717
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-168 Lilly Labeling Approved
Humulin 70/30
NDA #019717
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-168 Lilly Labeling Approved
Humulin 70/30
NDA #019717
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-169 Lilly Labeling Approved
Humulin 70/30 Pen
NDA #019717
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-168 Lilly Labeling Approved
Humulin 70/30 Pen
NDA #019717
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-168 Lilly Labeling Approved
Humulin 70/30 Pen
NDA #019717
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-169 Lilly Labeling Approved
Humulin N
NDA #018781
Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-187 Lilly Labeling Approved
Humulin N
NDA #018781
Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-187 Lilly Labeling Approved
Humulin N
NDA #018781
Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-188 Lilly Labeling Approved
Humulin R
NDA #018780
Insulin Human Solution; Subcutaneous SUPPL-175 Lilly Labeling Approved
Humulin R
NDA #018780
Insulin Human Solution; Subcutaneous SUPPL-175 Lilly Labeling Approved
Humulin R
NDA #018780
Insulin Human Solution; Subcutaneous SUPPL-176 Lilly Labeling Approved
Humulin R
NDA #018780
Insulin Recombinant Human Injectable; Injection SUPPL-175 Lilly Labeling Approved
Humulin R
NDA #018780
Insulin Recombinant Human Injectable; Injection SUPPL-175 Lilly Labeling Approved
Humulin R
NDA #018780
Insulin Recombinant Human Injectable; Injection SUPPL-176 Lilly Labeling Approved
Humulin R Kwikpen
NDA #018780
Insulin Human Solution; Subcutaneous SUPPL-175 Lilly Labeling Approved
Humulin R Kwikpen
NDA #018780
Insulin Human Solution; Subcutaneous SUPPL-175 Lilly Labeling Approved
Humulin R Kwikpen
NDA #018780
Insulin Human Solution; Subcutaneous SUPPL-176 Lilly Labeling Approved
Humulin R Pen
NDA #018780
Insulin Recombinant Human Injectable; Injection SUPPL-175 Lilly Labeling Approved
Humulin R Pen
NDA #018780
Insulin Recombinant Human Injectable; Injection SUPPL-175 Lilly Labeling Approved
Humulin R Pen
NDA #018780
Insulin Recombinant Human Injectable; Injection SUPPL-176 Lilly Labeling Approved
Lantus
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-73 Sanofi Aventis Us Labeling Approved
Lantus
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-73 Sanofi Aventis Us Labeling Approved
Lantus
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-74 Sanofi Aventis Us Labeling Approved
Lantus
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-73 Sanofi Aventis Us Labeling Approved
Lantus
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-74 Sanofi Aventis Us Labeling Approved
Lantus Solostar
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-73 Sanofi Aventis Us Labeling Approved
Lantus Solostar
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-73 Sanofi Aventis Us Labeling Approved
Lantus Solostar
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-74 Sanofi Aventis Us Labeling Approved
Lantus Solostar
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-73 Sanofi Aventis Us Labeling Approved
Lantus Solostar
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-74 Sanofi Aventis Us Labeling Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Mirtazapine
ANDA #077376
Mirtazapine Tablet, Orally Disintegrating; Oral SUPPL-16 Aurobindo Pharma Ltd Labeling Approved
Mirtazapine
ANDA #077376
Mirtazapine Tablet, Orally Disintegrating; Oral SUPPL-17 Aurobindo Pharma Ltd Labeling Approved
Mirtazapine
ANDA #077376
Mirtazapine Tablet, Orally Disintegrating; Oral SUPPL-22 Aurobindo Pharma Ltd Labeling Approved
Naproxen
ANDA #074190
Naproxen Suspension; Oral SUPPL-13 Hikma Labeling Approved
Naproxen
ANDA #074190
Naproxen Suspension; Oral SUPPL-14 Hikma Labeling Approved
Naproxen
ANDA #074190
Naproxen Suspension; Oral SUPPL-15 Hikma Labeling Approved
Nicorette
NDA #020066
Nicotine Polacrilex Gum, Chewing; Buccal SUPPL-64 Glaxosmithkline Labeling Approved
Nicorette (Mint)
NDA #020066
Nicotine Polacrilex Gum, Chewing; Buccal SUPPL-64 Glaxosmithkline Labeling Approved
Novolin 70/30
NDA #019991
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-82 Novo Nordisk Inc Labeling Approved
Novolin N
NDA #019959
Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-82 Novo Nordisk Inc Labeling Approved
Novolin N
NDA #019959
Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-82 Novo Nordisk Inc Labeling Approved
Novolin R
NDA #019938
Insulin Recombinant Human Injectable; Injection SUPPL-79 Novo Nordisk Inc Labeling Approved
Novolin R
NDA #019938
Insulin Recombinant Human Injectable; Injection SUPPL-79 Novo Nordisk Inc Labeling Approved
Novolog
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-91 Novo Nordisk Inc Labeling Approved
Novolog Flexpen
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Flexpen
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Flexpen
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-91 Novo Nordisk Inc Labeling Approved
Novolog Flextouch
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Flextouch
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Flextouch
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-91 Novo Nordisk Inc Labeling Approved
Novolog Innolet
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Innolet
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Innolet
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-91 Novo Nordisk Inc Labeling Approved
Novolog Mix 50/50
NDA #021810
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-18 Novo Nordisk Inc Labeling Approved
Novolog Mix 50/50
NDA #021810
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-18 Novo Nordisk Inc Labeling Approved
Novolog Mix 50/50
NDA #021810
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-19 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-71 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-71 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-72 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Flexpen
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-71 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Flexpen
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-71 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Flexpen
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-72 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Penfill
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-71 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Penfill
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-71 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Penfill
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-72 Novo Nordisk Inc Labeling Approved
Novolog Penfill
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Penfill
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Penfill
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-91 Novo Nordisk Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078894
Pramipexole Dihydrochloride Tablet; Oral SUPPL-4 Alembic Pharms Ltd Labeling Approved
Pramipexole Dihydrochloride
ANDA #078894
Pramipexole Dihydrochloride Tablet; Oral SUPPL-7 Alembic Pharms Ltd Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-12 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-9 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-10 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-14 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-15 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-14 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-15 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #090151
Pramipexole Dihydrochloride Tablet; Oral SUPPL-5 Apotex Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #090151
Pramipexole Dihydrochloride Tablet; Oral SUPPL-6 Apotex Inc Labeling Approved
Prednisone
ANDA #211575
Prednisone Tablet; Oral ORIG-1 Novitium Pharma Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-4 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-2 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-3 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-4 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-5 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-2 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-3 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-4 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-5 Amneal Pharms Labeling Approved
Ryzodeg 70/30
NDA #203313
Insulin Aspart; Insulin Degludec Solution; Subcutaneous SUPPL-9 Novo Labeling Approved
Ryzodeg 70/30
NDA #203313
Insulin Aspart; Insulin Degludec Solution; Subcutaneous SUPPL-9 Novo Labeling Approved
Ryzodeg 70/30
NDA #203313
Insulin Aspart; Insulin Degludec Solution; Subcutaneous SUPPL-10 Novo Labeling Approved
Ryzodeg 70/30
NDA #203313
Insulin Aspart; Insulin Degludec Solution; Subcutaneous SUPPL-10 Novo Labeling Approved
Soliqua 100/33
NDA #208673
Insulin Glargine; Lixisenatide Solution; Subcutaneous SUPPL-8 Sanofi-Aventis Us Labeling Approved
Soliqua 100/33
NDA #208673
Insulin Glargine; Lixisenatide Solution; Subcutaneous SUPPL-9 Sanofi-Aventis Us Labeling Approved
Soliqua 100/33
NDA #208673
Insulin Glargine; Lixisenatide Solution; Subcutaneous SUPPL-8 Sanofi-Aventis Us Labeling Approved
Soliqua 100/33
NDA #208673
Insulin Glargine; Lixisenatide Solution; Subcutaneous SUPPL-9 Sanofi-Aventis Us Labeling Approved
Toujeo Max Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-13 Sanofi Us Services Labeling Approved
Toujeo Max Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-13 Sanofi Us Services Labeling Approved
Toujeo Max Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-14 Sanofi Us Services Labeling Approved
Toujeo Max Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-14 Sanofi Us Services Labeling Approved
Toujeo Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-13 Sanofi Us Services Labeling Approved
Toujeo Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-13 Sanofi Us Services Labeling Approved
Toujeo Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-14 Sanofi Us Services Labeling Approved
Toujeo Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-14 Sanofi Us Services Labeling Approved
Tresiba
NDA #203314
Insulin Degludec Solution; Subcutaneous SUPPL-15 Novo Labeling Approved
Tresiba
NDA #203314
Insulin Degludec Solution; Subcutaneous SUPPL-15 Novo Labeling Approved
Tresiba
NDA #203314
Insulin Degludec Solution; Subcutaneous SUPPL-16 Novo Labeling Approved
Vosevi
NDA #209195
Sofosbuvir; Velpatasvir; Voxilaprevir Tablet; Oral SUPPL-3 Gilead Sciences Inc Efficacy Approved
Xarelto
NDA #022406
Rivaroxaban Tablet; Oral SUPPL-27 Janssen Pharms Labeling Approved
Xarelto
NDA #202439
Rivaroxaban Tablet; Oral SUPPL-34 Janssen Pharms Labeling Approved
Xultophy 100/3.6
NDA #208583
Insulin Degludec; Liraglutide Solution; Subcutaneous SUPPL-14 Novo Labeling Approved
Xultophy 100/3.6
NDA #208583
Insulin Degludec; Liraglutide Solution; Subcutaneous SUPPL-15 Novo Labeling Approved
Xultophy 100/3.6
NDA #208583
Insulin Degludec; Liraglutide Solution; Subcutaneous SUPPL-14 Novo Labeling Approved
Xultophy 100/3.6
NDA #208583
Insulin Degludec; Liraglutide Solution; Subcutaneous SUPPL-15 Novo Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-23 Teva Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-24 Teva Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-17 Teva Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-19 Teva Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-21 Teva Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-23 Teva Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-24 Teva Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-5 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-6 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-7 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-2 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-3 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-4 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-5 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-6 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-7 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #201509
Zolpidem Tartrate Tablet; Sublingual SUPPL-1 Par Form Labeling Approved
Zolpidem Tartrate
ANDA #201509
Zolpidem Tartrate Tablet; Sublingual SUPPL-1 Par Form Labeling Approved
Zolpidem Tartrate
ANDA #201509
Zolpidem Tartrate Tablet; Sublingual SUPPL-2 Par Form Labeling Approved

November 14, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Brukinsa
NDA #213217
Zanubrutinib Capsule; Oral ORIG-1 Beigene Usa Inc Type 1 - New Molecular Entity Approved
Buspirone Hydrochloride
ANDA #210907
Buspirone Hydrochloride Tablet; Oral ORIG-1 Unichem Labs Ltd Approved
Celecoxib
ANDA #208701
Celecoxib Capsule; Oral ORIG-1 Cadila Pharms Ltd Approved
Clobetasol Propionate
ANDA #077763
Clobetasol Propionate Aerosol, Foam; Topical SUPPL-11 Perrigo Israel Labeling Approved
Clobetasol Propionate
ANDA #077763
Clobetasol Propionate Aerosol, Foam; Topical SUPPL-13 Perrigo Israel Labeling Approved
Clobetasol Propionate (Emollient)
ANDA #075633
Clobetasol Propionate Cream; Topical SUPPL-10 Taro Labeling Approved
Didanosine
ANDA #090094
Didanosine Capsule, Delayed Rel Pellets; Oral SUPPL-13 Aurobindo Pharma Labeling Approved
Didanosine
ANDA #090094
Didanosine Capsule, Delayed Rel Pellets; Oral SUPPL-14 Aurobindo Pharma Labeling Approved
Didanosine
ANDA #090094
Didanosine Capsule, Delayed Rel Pellets; Oral SUPPL-13 Aurobindo Pharma Labeling Approved
Didanosine
ANDA #090094
Didanosine Capsule, Delayed Rel Pellets; Oral SUPPL-14 Aurobindo Pharma Labeling Approved
Doxercalciferol
ANDA #203875
Doxercalciferol Injectable; Injection ORIG-1 Sun Pharm Approved
Emend
NDA #021549
Aprepitant Capsule; Oral SUPPL-30 Merck Labeling Approved
Emend
NDA #022023
Fosaprepitant Dimeglumine Powder; Intravenous SUPPL-19 Merck and Co Inc Labeling Approved
Emend
NDA #207865
Aprepitant For Suspension; Oral SUPPL-3 Msd Merck Co Labeling Approved
Fetroja
NDA #209445
Cefiderocol Sulfate Tosylate Powder; Intravenous ORIG-1 Shionogi Inc Type 1 - New Molecular Entity Approved
Fluticasone Propionate
ANDA #077570
Fluticasone Propionate Spray, Metered; Nasal SUPPL-13 Hi Tech Pharma Labeling Approved
Fluticasone Propionate
ANDA #077570
Fluticasone Propionate Spray, Metered; Nasal SUPPL-13 Hi Tech Pharma Labeling Approved
Fluticasone Propionate
ANDA #090759
Fluticasone Propionate Lotion; Topical SUPPL-5 Glenmark Generics Labeling Approved
Fluticasone Propionate
ANDA #090759
Fluticasone Propionate Lotion; Topical SUPPL-3 Glenmark Generics Labeling Approved
Fluticasone Propionate
ANDA #090759
Fluticasone Propionate Lotion; Topical SUPPL-5 Glenmark Generics Labeling Approved
Furosemide
ANDA #202747
Furosemide Injectable; Injection SUPPL-3 Baxter Hlthcare Corp Labeling Approved
Gemcitabine Hydrochloride
ANDA #202063
Gemcitabine Hydrochloride Injectable; Injection SUPPL-9 Emcure Pharms Ltd Labeling Approved
Gemcitabine Hydrochloride
ANDA #202063
Gemcitabine Hydrochloride Injectable; Injection SUPPL-8 Emcure Pharms Ltd Labeling Approved
Gemcitabine Hydrochloride
ANDA #202063
Gemcitabine Hydrochloride Injectable; Injection SUPPL-7 Emcure Pharms Ltd Labeling Approved
Gemcitabine Hydrochloride
ANDA #202063
Gemcitabine Hydrochloride Injectable; Injection SUPPL-8 Emcure Pharms Ltd Labeling Approved
Hysingla Er
NDA #206627
Hydrocodone Bitartrate Tablet, Extended Release; Oral SUPPL-9 Purdue Pharma Lp REMS Approved
Metformin Hydrochloride
ANDA #075969
Metformin Hydrochloride Tablet; Oral SUPPL-11 Mylan Pharms Inc Labeling Approved
Metformin Hydrochloride
ANDA #075969
Metformin Hydrochloride Tablet; Oral SUPPL-12 Mylan Pharms Inc Labeling Approved
Metformin Hydrochloride
ANDA #075969
Metformin Hydrochloride Tablet; Oral SUPPL-11 Mylan Pharms Inc Labeling Approved
Metformin Hydrochloride
ANDA #075969
Metformin Hydrochloride Tablet; Oral SUPPL-12 Mylan Pharms Inc Labeling Approved
Metformin Hydrochloride
ANDA #075976
Metformin Hydrochloride Tablet; Oral SUPPL-20 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #075976
Metformin Hydrochloride Tablet; Oral SUPPL-21 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #075976
Metformin Hydrochloride Tablet; Oral SUPPL-20 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #075976
Metformin Hydrochloride Tablet; Oral SUPPL-21 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #076650
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-7 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #076650
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #076650
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-7 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #076650
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #077113
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #077113
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-9 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #077113
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-9 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #209303
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-2 Alignscience Pharma Labeling Approved
Methamphetamine Hydrochloride
ANDA #091189
Methamphetamine Hydrochloride Tablet; Oral SUPPL-6 Mayne Pharma Inc Labeling Approved
Methamphetamine Hydrochloride
ANDA #091189
Methamphetamine Hydrochloride Tablet; Oral SUPPL-5 Mayne Pharma Inc Labeling Approved
Methamphetamine Hydrochloride
ANDA #091189
Methamphetamine Hydrochloride Tablet; Oral SUPPL-4 Mayne Pharma Inc Labeling Approved
Methamphetamine Hydrochloride
ANDA #091189
Methamphetamine Hydrochloride Tablet; Oral SUPPL-5 Mayne Pharma Inc Labeling Approved
Methamphetamine Hydrochloride
ANDA #091189
Methamphetamine Hydrochloride Tablet; Oral SUPPL-6 Mayne Pharma Inc Labeling Approved
Miglustat
ANDA #208342
Miglustat Capsule; Oral SUPPL-1 Amerigen Pharms Ltd Labeling Approved
Oxycontin
NDA #022272
Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-42 Purdue Pharma Lp REMS Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-11 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-11 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-13 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-14 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-11 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-13 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-14 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-16 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-22 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-16 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-22 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-13 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-10 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-13 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Aurobindo Pharma Ltd Labeling Approved
Propafenone Hydrochloride
ANDA #205956
Propafenone Hydrochloride Capsule, Extended Release; Oral SUPPL-3 Wilshire Pharms Inc Labeling Approved
Quetiapine Fumarate
ANDA #090960
Quetiapine Fumarate Tablet; Oral SUPPL-10 Apotex Inc Labeling Approved
Quetiapine Fumarate
ANDA #090960
Quetiapine Fumarate Tablet; Oral SUPPL-10 Apotex Inc Labeling Approved
Quetiapine Fumarate
ANDA #090960
Quetiapine Fumarate Tablet; Oral SUPPL-11 Apotex Inc Labeling Approved
Ropivacaine Hydrochloride
ANDA #206166
Ropivacaine Hydrochloride Solution; Injection SUPPL-3 Inforlife Labeling Approved
Ropivacaine Hydrochloride
ANDA #206166
Ropivacaine Hydrochloride Solution; Injection SUPPL-3 Inforlife Labeling Approved
Spironolactone
ANDA #040424
Spironolactone Tablet; Oral SUPPL-21 Mylan Labeling Approved
Spironolactone
ANDA #203253
Spironolactone Tablet; Oral SUPPL-5 Jubilant Generics Labeling Approved
Temozolomide
ANDA #078879
Temozolomide Capsule; Oral SUPPL-15 Barr Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-2 Ipca Labs Ltd Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-4 Ipca Labs Ltd Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-5 Ipca Labs Ltd Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-1 Ipca Labs Ltd Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-2 Ipca Labs Ltd Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-4 Ipca Labs Ltd Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-5 Ipca Labs Ltd Labeling Approved

November 13, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Lumason
NDA #203684
Sulfur Hexafluoride Lipid-Type A Microspheres For Suspension; Intravenous SUPPL-5 Bracco Efficacy Approved
Meloxicam
ANDA #077938
Meloxicam Tablet; Oral SUPPL-4 Puracap Pharm Labeling Approved
Midazolam Hydrochloride
ANDA #208878
Midazolam Hydrochloride Injectable; Injection SUPPL-1 Fresenius Kabi Usa Labeling Approved
Midodrine Hydrochloride
ANDA #076449
Midodrine Hydrochloride Tablet; Oral SUPPL-14 Impax Pharms Labeling Approved
Midodrine Hydrochloride
ANDA #077746
Midodrine Hydrochloride Tablet; Oral SUPPL-7 Apotex Labeling Approved
Midodrine Hydrochloride
ANDA #077746
Midodrine Hydrochloride Tablet; Oral SUPPL-7 Apotex Labeling Approved
Orvaten
ANDA #076725
Midodrine Hydrochloride Tablet; Oral SUPPL-17 Upsher Smith Labs Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-5 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-6 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-7 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-5 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-6 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-7 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-8 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-9 Rubicon Labeling Approved
Procainamide Hydrochloride
ANDA #088636
Procainamide Hydrochloride Injectable; Injection SUPPL-15 Intl Medication Labeling Approved
Propafenone Hydrochloride
ANDA #075203
Propafenone Hydrochloride Tablet; Oral SUPPL-17 Watson Labs Labeling Approved
Propafenone Hydrochloride
ANDA #075203
Propafenone Hydrochloride Tablet; Oral SUPPL-17 Watson Labs Labeling Approved
Propafenone Hydrochloride
ANDA #202445
Propafenone Hydrochloride Tablet; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Propafenone Hydrochloride
ANDA #202445
Propafenone Hydrochloride Tablet; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved

November 12, 2019

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Daptomycin
ANDA #091039
Daptomycin Powder; Intravenous SUPPL-2 Teva Pharms Usa Labeling Approved
Daptomycin
ANDA #091039
Daptomycin Powder; Intravenous SUPPL-3 Teva Pharms Usa Labeling Approved
Daptomycin
ANDA #091039
Daptomycin Powder; Intravenous SUPPL-4 Teva Pharms Usa Labeling Approved
Eszopiclone
ANDA #091166
Eszopiclone Tablet; Oral SUPPL-4 Glenmark Generics Labeling Approved
Eszopiclone
ANDA #091166
Eszopiclone Tablet; Oral SUPPL-5 Glenmark Generics Labeling Approved
Eszopiclone
ANDA #091166
Eszopiclone Tablet; Oral SUPPL-4 Glenmark Generics Labeling Approved
Eszopiclone
ANDA #091166
Eszopiclone Tablet; Oral SUPPL-5 Glenmark Generics Labeling Approved
Eszopiclone
ANDA #091166
Eszopiclone Tablet; Oral SUPPL-6 Glenmark Generics Labeling Approved
Indomethacin
ANDA #070673
Indomethacin Capsule; Oral SUPPL-20 Sandoz Labeling Approved
Indomethacin
ANDA #070673
Indomethacin Capsule; Oral SUPPL-21 Sandoz Labeling Approved
Indomethacin
ANDA #070674
Indomethacin Capsule; Oral SUPPL-20 Sandoz Labeling Approved
Indomethacin
ANDA #070674
Indomethacin Capsule; Oral SUPPL-21 Sandoz Labeling Approved
Itraconazole
ANDA #205724
Itraconazole Capsule; Oral SUPPL-1 Par Pharm Inc Labeling Approved
Itraconazole
ANDA #205724
Itraconazole Capsule; Oral SUPPL-2 Par Pharm Inc Labeling Approved
Itraconazole
ANDA #205724
Itraconazole Capsule; Oral SUPPL-4 Par Pharm Inc Labeling Approved
Itraconazole
ANDA #205724
Itraconazole Capsule; Oral SUPPL-1 Par Pharm Inc Labeling Approved
Itraconazole
ANDA #205724
Itraconazole Capsule; Oral SUPPL-4 Par Pharm Inc Labeling Approved
Risperidone
ANDA #078871
Risperidone Tablet; Oral SUPPL-5 Celltrion Labeling Approved
Risperidone
ANDA #078871
Risperidone Tablet; Oral SUPPL-6 Celltrion Labeling Approved
Risperidone
ANDA #078871
Risperidone Tablet; Oral SUPPL-7 Celltrion Labeling Approved
Risperidone
ANDA #201003
Risperidone Tablet; Oral SUPPL-10 Ajanta Pharma Ltd Labeling Approved
Risperidone
ANDA #201003
Risperidone Tablet; Oral SUPPL-14 Ajanta Pharma Ltd Labeling Approved
Risperidone
ANDA #201003
Risperidone Tablet; Oral SUPPL-16 Ajanta Pharma Ltd Labeling Approved

November 21, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Calquence
NDA #210259
Acalabrutinib Capsule; Oral SUPPL-6 Astrazeneca Efficacy Approved
Calquence
NDA #210259
Acalabrutinib Capsule; Oral SUPPL-7 Astrazeneca Efficacy Approved

November 20, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cayston
NDA #050814
Aztreonam For Solution; Inhalation SUPPL-23 Gilead Labeling Approved
Deferasirox
ANDA #209782
Deferasirox Tablet, For Suspension; Oral ORIG-1 Sun Pharm Approved
Deferasirox
ANDA #209878
Deferasirox Tablet, For Suspension; Oral ORIG-1 Msn Labs Pvt Ltd Approved
Deferasirox
ANDA #210060
Deferasirox Tablet, For Suspension; Oral ORIG-1 Alembic Pharms Ltd Approved
Deferasirox
ANDA #210519
Deferasirox Tablet, For Suspension; Oral ORIG-1 Alkem Labs Ltd Approved
Deferasirox
ANDA #210920
Deferasirox Tablet, For Suspension; Oral ORIG-1 Bionpharma Inc Approved
Deferasirox
ANDA #210945
Deferasirox Tablet; Oral ORIG-1 Msn Labs Pvt Ltd Approved
Deferasirox
ANDA #210945
Deferasirox Tablet; Oral ORIG-2 Msn Labs Pvt Ltd Tentative Approval
Desonide
ANDA #210198
Desonide Cream; Topical ORIG-1 Zydus Pharms Approved
Fosamprenavir Calcium
ANDA #204024
Fosamprenavir Calcium Tablet; Oral ORIG-1 Sun Pharm Approved
Givlaari
NDA #212194
Givosiran Injectable; Injection ORIG-1 Alnylam Pharms Inc Type 1 - New Molecular Entity Approved
Lamotrigine
ANDA #077420
Lamotrigine Tablet; Oral SUPPL-17 Mylan Labeling Approved
Lamotrigine
ANDA #077420
Lamotrigine Tablet; Oral SUPPL-18 Mylan Labeling Approved
Lamotrigine
ANDA #077420
Lamotrigine Tablet; Oral SUPPL-17 Mylan Labeling Approved
Lamotrigine
ANDA #077420
Lamotrigine Tablet; Oral SUPPL-18 Mylan Labeling Approved
Mesalamine
ANDA #207271
Mesalamine Capsule, Extended Release; Oral ORIG-1 Mylan Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-1 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-2 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-3 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-4 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-1 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-2 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-3 Apotex Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #206481
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-4 Apotex Labeling Approved

November 19, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Focalin
NDA #021278
Dexmethylphenidate Hydrochloride Tablet; Oral SUPPL-26 Novartis Labeling Approved
Focalin Xr
NDA #021802
Dexmethylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-36 Novartis Labeling Approved
Ivermectin
ANDA #212485
Ivermectin Unknown ORIG-1 Teva Pharms Usa Tentative Approval
Ritalin
NDA #010187
Methylphenidate Hydrochloride Tablet; Oral SUPPL-91 Novartis Labeling Approved
Ritalin La
NDA #021284
Methylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-41 Novartis Labeling Approved
Ritalin-Sr
NDA #018029
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-59 Novartis Labeling Approved
Tavaborole
ANDA #212215
Tavaborole Unknown ORIG-1 Taro Pharma Usa Inc Tentative Approval
Tenofovir Disoproxil Fumarate
ANDA #078800
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-18 Cipla Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #078800
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-17 Cipla Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #078800
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-18 Cipla Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #078800
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-19 Cipla Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #078800
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-20 Cipla Labeling Approved
Tenofovir Disoproxil Fumarate
ANDA #090742
Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-12 Strides Pharma Labeling Approved
Turalio
NDA #211810
Pexidartinib Hydrochloride Capsule; Oral SUPPL-1 Daiichi Sankyo Inc REMS Approved
Turalio
NDA #211810
Pexidartinib Hydrochloride Capsule; Oral SUPPL-2 Daiichi Sankyo Inc REMS Approved
Xyosted (Autoinjector)
NDA #209863
Testosterone Enanthate Solution; Subcutaneous SUPPL-2 Antares Pharma Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-15 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-16 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-17 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-18 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-15 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-16 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-17 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #077322
Zolpidem Tartrate Tablet; Oral SUPPL-18 Sandoz Inc Labeling Approved
Zolpidem Tartrate
ANDA #078148
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-11 Anchen Pharms Labeling Approved
Zolpidem Tartrate
ANDA #078148
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-12 Anchen Pharms Labeling Approved
Zolpidem Tartrate
ANDA #078148
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-13 Anchen Pharms Labeling Approved
Zolpidem Tartrate
ANDA #078148
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-15 Anchen Pharms Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-14 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-15 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-16 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-14 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-15 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-16 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #078179
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-15 Actavis Elizabeth Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-6 Sandoz Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-8 Sandoz Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-9 Sandoz Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-6 Sandoz Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-7 Sandoz Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-8 Sandoz Labeling Approved
Zolpidem Tartrate
ANDA #090107
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-9 Sandoz Labeling Approved

November 18, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amlodipine Besylate and Atorvastatin Calcium
ANDA #205199
Amlodipine Besylate; Atorvastatin Calcium Tablet; Oral ORIG-1 Apotex Approved
Ampicillin Sodium
ANDA #090581
Ampicillin Sodium Injectable; Injection SUPPL-3 Sagent Pharms Inc Labeling Approved
Diltiazem Hydrochloride
ANDA #211596
Diltiazem Hydrochloride Tablet; Oral ORIG-1 Edenbridge Pharms Approved
Ecoza
NDA #205175
Econazole Nitrate Aerosol, Foam; Topical SUPPL-3 Glenmark Labeling Approved
Irinotecan Hydrochloride
ANDA #212993
Irinotecan Hydrochloride Injectable; Injection ORIG-1 Gland Pharma Ltd Approved
Nystatin and Triamcinolone Acetonide
ANDA #207316
Nystatin; Triamcinolone Acetonide Ointment; Topical ORIG-1 Vitruvias Therap Approved
Tacrolimus
ANDA #090802
Tacrolimus Capsule; Oral SUPPL-7 Panacea Biotec Ltd Labeling Approved
Tylenol W/ Codeine No. 1
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-63 Janssen Pharms Labeling Approved
Tylenol W/ Codeine No. 2
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-63 Janssen Pharms Labeling Approved
Tylenol W/ Codeine No. 3
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-63 Janssen Pharms Labeling Approved
Tylenol W/ Codeine No. 4
ANDA #085055
Acetaminophen; Codeine Phosphate Tablet; Oral SUPPL-63 Janssen Pharms Labeling Approved

November 16, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ampicillin and Sulbactam
ANDA #065176
Ampicillin Sodium; Sulbactam Sodium Injectable; Injection SUPPL-14 Hanford Gc Labeling Approved
Ampicillin and Sulbactam
ANDA #065188
Ampicillin Sodium; Sulbactam Sodium Injectable; Injection SUPPL-16 Hanford Gc Labeling Approved
Cefuroxime
ANDA #065048
Cefuroxime Injectable; Injection SUPPL-17 Hikma Farmaceutica Labeling Approved
Cefuroxime Sodium
ANDA #065046
Cefuroxime Sodium Injectable; Injection SUPPL-11 Hikma Farmaceutica Labeling Approved
Cefuroxime Sodium
ANDA #065048
Cefuroxime Sodium Injectable; Injection SUPPL-17 Hikma Farmaceutica Labeling Approved
Cefuroxime Sodium
ANDA #065048
Cefuroxime Sodium Injectable; Intramuscular, Intravenous SUPPL-17 Hikma Farmaceutica Labeling Approved

November 15, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Abrilada
BLA #761118
Adalimumab-Afzb Injectable; Injection ORIG-1 Pfizer Inc Type 2 - New Active Ingredient Approved
Adakveo
BLA #761128
Crizanlizumab-Tmca Injectable; Injection ORIG-1 Novartis Pharms Corp Type 1 - New Molecular Entity Approved
Admelog
NDA #209196
Insulin Lispro Solution; Intravenous, Subcutaneous SUPPL-4 Sanofi-Aventis Us Labeling Approved
Admelog
NDA #209196
Insulin Lispro Solution; Intravenous, Subcutaneous SUPPL-5 Sanofi-Aventis Us Labeling Approved
Admelog Solostar
NDA #209196
Insulin Lispro Solution; Intravenous, Subcutaneous SUPPL-4 Sanofi-Aventis Us Labeling Approved
Admelog Solostar
NDA #209196
Insulin Lispro Solution; Intravenous, Subcutaneous SUPPL-5 Sanofi-Aventis Us Labeling Approved
Apidra
NDA #021629
Insulin Glulisine Recombinant Injectable; Intravenous, Subcutaneous SUPPL-39 Sanofi Aventis Us Labeling Approved
Apidra
NDA #021629
Insulin Glulisine Recombinant Injectable; Intravenous, Subcutaneous SUPPL-39 Sanofi Aventis Us Labeling Approved
Apidra
NDA #021629
Insulin Glulisine Recombinant Injectable; Intravenous, Subcutaneous SUPPL-40 Sanofi Aventis Us Labeling Approved
Apidra
NDA #021629
Insulin Glulisine Recombinant Injectable; Intravenous, Subcutaneous SUPPL-40 Sanofi Aventis Us Labeling Approved
Apidra Solostar
NDA #021629
Insulin Glulisine Recombinant Injectable; Subcutaneous SUPPL-39 Sanofi Aventis Us Labeling Approved
Apidra Solostar
NDA #021629
Insulin Glulisine Recombinant Injectable; Subcutaneous SUPPL-39 Sanofi Aventis Us Labeling Approved
Apidra Solostar
NDA #021629
Insulin Glulisine Recombinant Injectable; Subcutaneous SUPPL-40 Sanofi Aventis Us Labeling Approved
Apidra Solostar
NDA #021629
Insulin Glulisine Recombinant Injectable; Subcutaneous SUPPL-40 Sanofi Aventis Us Labeling Approved
Apremilast
ANDA #211859
Apremilast Unknown ORIG-1 Zydus Pharms Usa Inc Tentative Approval
Basaglar
NDA #205692
Insulin Glargine Solution; Subcutaneous SUPPL-21 Eli Lilly and Co Labeling Approved
Basaglar
NDA #205692
Insulin Glargine Solution; Subcutaneous SUPPL-24 Eli Lilly and Co Labeling Approved
Basaglar
NDA #205692
Insulin Glargine Solution; Subcutaneous SUPPL-21 Eli Lilly and Co Labeling Approved
Basaglar
NDA #205692
Insulin Glargine Solution; Subcutaneous SUPPL-24 Eli Lilly and Co Labeling Approved
Basaglar
NDA #205692
Insulin Glargine Solution; Subcutaneous SUPPL-25 Eli Lilly and Co Labeling Approved
Basaglar
NDA #205692
Insulin Glargine Solution; Subcutaneous SUPPL-21 Eli Lilly and Co Labeling Approved
Blisovi 24 Fe
ANDA #091398
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-14 Lupin Ltd Manufacturing (CMC) Approved
Clobetasol Propionate
ANDA #211295
Clobetasol Propionate Ointment; Topical ORIG-1 Encube Approved
Daptomycin
ANDA #207104
Daptomycin Powder; Intravenous ORIG-1 Sagent Pharms Inc Approved
Enskyce
ANDA #201887
Desogestrel; Ethinyl Estradiol Tablet; Oral-28 SUPPL-15 Lupin Ltd Manufacturing (CMC) Approved
Epclusa
NDA #208341
Sofosbuvir; Velpatasvir Tablet; Oral SUPPL-12 Gilead Sciences Inc Efficacy Approved
Fiasp
NDA #208751
Insulin Aspart Solution; Intravenous, Subcutaneous SUPPL-12 Novo Labeling Approved
Fiasp
NDA #208751
Insulin Aspart Solution; Intravenous, Subcutaneous SUPPL-12 Novo Labeling Approved
Fiasp Flextouch
NDA #208751
Insulin Aspart Solution; Subcutaneous SUPPL-12 Novo Labeling Approved
Fiasp Flextouch
NDA #208751
Insulin Aspart Solution; Subcutaneous SUPPL-12 Novo Labeling Approved
Fiasp Penfill
NDA #208751
Insulin Aspart Solution; Subcutaneous SUPPL-12 Novo Labeling Approved
Fiasp Penfill
NDA #208751
Insulin Aspart Solution; Subcutaneous SUPPL-12 Novo Labeling Approved
Harvoni
NDA #205834
Ledipasvir; Sofosbuvir Tablet; Oral SUPPL-28 Gilead Sciences Inc Efficacy Approved
Harvoni
NDA #212477
Ledipasvir; Sofosbuvir Pellets; Oral SUPPL-2 Gilead Sciences Inc Efficacy Approved
Humalog
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-198 Lilly Labeling Approved
Humalog
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-198 Lilly Labeling Approved
Humalog
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-199 Lilly Labeling Approved
Humalog
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog Kwikpen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog Kwikpen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-198 Lilly Labeling Approved
Humalog Kwikpen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog Kwikpen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-198 Lilly Labeling Approved
Humalog Kwikpen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-199 Lilly Labeling Approved
Humalog Kwikpen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog Kwikpen
NDA #205747
Insulin Lispro Recombinant Solution; Subcutaneous SUPPL-22 Eli Lilly and Co Labeling Approved
Humalog Kwikpen
NDA #205747
Insulin Lispro Recombinant Solution; Subcutaneous SUPPL-25 Eli Lilly and Co Labeling Approved
Humalog Kwikpen
NDA #205747
Insulin Lispro Recombinant Solution; Subcutaneous SUPPL-22 Eli Lilly and Co Labeling Approved
Humalog Kwikpen
NDA #205747
Insulin Lispro Recombinant Solution; Subcutaneous SUPPL-26 Eli Lilly and Co Labeling Approved
Humalog Kwikpen
NDA #205747
Insulin Lispro Recombinant Solution; Subcutaneous SUPPL-22 Eli Lilly and Co Labeling Approved
Humalog Mix 50/50
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-127 Lilly Labeling Approved
Humalog Mix 50/50
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-127 Lilly Labeling Approved
Humalog Mix 50/50
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-129 Lilly Labeling Approved
Humalog Mix 50/50 Kwikpen
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-127 Lilly Labeling Approved
Humalog Mix 50/50 Kwikpen
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-127 Lilly Labeling Approved
Humalog Mix 50/50 Kwikpen
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-129 Lilly Labeling Approved
Humalog Mix 50/50 Pen
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-127 Lilly Labeling Approved
Humalog Mix 50/50 Pen
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-127 Lilly Labeling Approved
Humalog Mix 50/50 Pen
NDA #021018
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-129 Lilly Labeling Approved
Humalog Mix 75/25
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-141 Lilly Labeling Approved
Humalog Mix 75/25
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-141 Lilly Labeling Approved
Humalog Mix 75/25
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-143 Lilly Labeling Approved
Humalog Mix 75/25 Kwikpen
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-141 Lilly Labeling Approved
Humalog Mix 75/25 Kwikpen
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-141 Lilly Labeling Approved
Humalog Mix 75/25 Kwikpen
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-143 Lilly Labeling Approved
Humalog Mix 75/25 Pen
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-141 Lilly Labeling Approved
Humalog Mix 75/25 Pen
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-141 Lilly Labeling Approved
Humalog Mix 75/25 Pen
NDA #021017
Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant Injectable; Injection SUPPL-143 Lilly Labeling Approved
Humalog Pen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog Pen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-198 Lilly Labeling Approved
Humalog Pen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humalog Pen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-198 Lilly Labeling Approved
Humalog Pen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-199 Lilly Labeling Approved
Humalog Pen
NDA #020563
Insulin Lispro Recombinant Injectable; Injection SUPPL-196 Lilly Labeling Approved
Humulin 70/30
NDA #019717
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-168 Lilly Labeling Approved
Humulin 70/30
NDA #019717
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-168 Lilly Labeling Approved
Humulin 70/30
NDA #019717
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-169 Lilly Labeling Approved
Humulin 70/30 Pen
NDA #019717
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-168 Lilly Labeling Approved
Humulin 70/30 Pen
NDA #019717
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-168 Lilly Labeling Approved
Humulin 70/30 Pen
NDA #019717
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-169 Lilly Labeling Approved
Humulin N
NDA #018781
Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-187 Lilly Labeling Approved
Humulin N
NDA #018781
Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-187 Lilly Labeling Approved
Humulin N
NDA #018781
Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-188 Lilly Labeling Approved
Humulin R
NDA #018780
Insulin Human Solution; Subcutaneous SUPPL-175 Lilly Labeling Approved
Humulin R
NDA #018780
Insulin Human Solution; Subcutaneous SUPPL-175 Lilly Labeling Approved
Humulin R
NDA #018780
Insulin Human Solution; Subcutaneous SUPPL-176 Lilly Labeling Approved
Humulin R
NDA #018780
Insulin Recombinant Human Injectable; Injection SUPPL-175 Lilly Labeling Approved
Humulin R
NDA #018780
Insulin Recombinant Human Injectable; Injection SUPPL-175 Lilly Labeling Approved
Humulin R
NDA #018780
Insulin Recombinant Human Injectable; Injection SUPPL-176 Lilly Labeling Approved
Humulin R Kwikpen
NDA #018780
Insulin Human Solution; Subcutaneous SUPPL-175 Lilly Labeling Approved
Humulin R Kwikpen
NDA #018780
Insulin Human Solution; Subcutaneous SUPPL-175 Lilly Labeling Approved
Humulin R Kwikpen
NDA #018780
Insulin Human Solution; Subcutaneous SUPPL-176 Lilly Labeling Approved
Humulin R Pen
NDA #018780
Insulin Recombinant Human Injectable; Injection SUPPL-175 Lilly Labeling Approved
Humulin R Pen
NDA #018780
Insulin Recombinant Human Injectable; Injection SUPPL-175 Lilly Labeling Approved
Humulin R Pen
NDA #018780
Insulin Recombinant Human Injectable; Injection SUPPL-176 Lilly Labeling Approved
Lantus
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-73 Sanofi Aventis Us Labeling Approved
Lantus
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-73 Sanofi Aventis Us Labeling Approved
Lantus
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-74 Sanofi Aventis Us Labeling Approved
Lantus
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-73 Sanofi Aventis Us Labeling Approved
Lantus
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-74 Sanofi Aventis Us Labeling Approved
Lantus Solostar
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-73 Sanofi Aventis Us Labeling Approved
Lantus Solostar
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-73 Sanofi Aventis Us Labeling Approved
Lantus Solostar
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-74 Sanofi Aventis Us Labeling Approved
Lantus Solostar
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-73 Sanofi Aventis Us Labeling Approved
Lantus Solostar
NDA #021081
Insulin Glargine Recombinant Injectable; Injection SUPPL-74 Sanofi Aventis Us Labeling Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Flexpen
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Flextouch
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Innolet
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-57 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Levemir Penfill
NDA #021536
Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-58 Novo Nordisk Inc Labeling Approved
Mirtazapine
ANDA #077376
Mirtazapine Tablet, Orally Disintegrating; Oral SUPPL-16 Aurobindo Pharma Ltd Labeling Approved
Mirtazapine
ANDA #077376
Mirtazapine Tablet, Orally Disintegrating; Oral SUPPL-17 Aurobindo Pharma Ltd Labeling Approved
Mirtazapine
ANDA #077376
Mirtazapine Tablet, Orally Disintegrating; Oral SUPPL-22 Aurobindo Pharma Ltd Labeling Approved
Naproxen
ANDA #074190
Naproxen Suspension; Oral SUPPL-13 Hikma Labeling Approved
Naproxen
ANDA #074190
Naproxen Suspension; Oral SUPPL-14 Hikma Labeling Approved
Naproxen
ANDA #074190
Naproxen Suspension; Oral SUPPL-15 Hikma Labeling Approved
Nicorette
NDA #020066
Nicotine Polacrilex Gum, Chewing; Buccal SUPPL-64 Glaxosmithkline Labeling Approved
Nicorette (Mint)
NDA #020066
Nicotine Polacrilex Gum, Chewing; Buccal SUPPL-64 Glaxosmithkline Labeling Approved
Novolin 70/30
NDA #019991
Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-82 Novo Nordisk Inc Labeling Approved
Novolin N
NDA #019959
Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-82 Novo Nordisk Inc Labeling Approved
Novolin N
NDA #019959
Insulin Susp Isophane Recombinant Human Injectable; Injection SUPPL-82 Novo Nordisk Inc Labeling Approved
Novolin R
NDA #019938
Insulin Recombinant Human Injectable; Injection SUPPL-79 Novo Nordisk Inc Labeling Approved
Novolin R
NDA #019938
Insulin Recombinant Human Injectable; Injection SUPPL-79 Novo Nordisk Inc Labeling Approved
Novolog
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-91 Novo Nordisk Inc Labeling Approved
Novolog Flexpen
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Flexpen
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Flexpen
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-91 Novo Nordisk Inc Labeling Approved
Novolog Flextouch
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Flextouch
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Flextouch
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-91 Novo Nordisk Inc Labeling Approved
Novolog Innolet
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Innolet
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Innolet
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-91 Novo Nordisk Inc Labeling Approved
Novolog Mix 50/50
NDA #021810
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-18 Novo Nordisk Inc Labeling Approved
Novolog Mix 50/50
NDA #021810
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-18 Novo Nordisk Inc Labeling Approved
Novolog Mix 50/50
NDA #021810
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-19 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-71 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-71 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-72 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Flexpen
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-71 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Flexpen
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-71 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Flexpen
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-72 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Penfill
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-71 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Penfill
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-71 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Penfill
NDA #021172
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-72 Novo Nordisk Inc Labeling Approved
Novolog Penfill
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Penfill
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-90 Novo Nordisk Inc Labeling Approved
Novolog Penfill
NDA #020986
Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-91 Novo Nordisk Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078894
Pramipexole Dihydrochloride Tablet; Oral SUPPL-4 Alembic Pharms Ltd Labeling Approved
Pramipexole Dihydrochloride
ANDA #078894
Pramipexole Dihydrochloride Tablet; Oral SUPPL-7 Alembic Pharms Ltd Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-12 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-9 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-10 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-14 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-15 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-14 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #078920
Pramipexole Dihydrochloride Tablet; Oral SUPPL-15 Zydus Pharms Usa Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #090151
Pramipexole Dihydrochloride Tablet; Oral SUPPL-5 Apotex Inc Labeling Approved
Pramipexole Dihydrochloride
ANDA #090151
Pramipexole Dihydrochloride Tablet; Oral SUPPL-6 Apotex Inc Labeling Approved
Prednisone
ANDA #211575
Prednisone Tablet; Oral ORIG-1 Novitium Pharma Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-4 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-2 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-3 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-4 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-5 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-2 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-3 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-4 Amneal Pharms Labeling Approved
Rabeprazole Sodium
ANDA #204179
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-5 Amneal Pharms Labeling Approved
Ryzodeg 70/30
NDA #203313
Insulin Aspart; Insulin Degludec Solution; Subcutaneous SUPPL-9 Novo Labeling Approved
Ryzodeg 70/30
NDA #203313
Insulin Aspart; Insulin Degludec Solution; Subcutaneous SUPPL-9 Novo Labeling Approved
Ryzodeg 70/30
NDA #203313
Insulin Aspart; Insulin Degludec Solution; Subcutaneous SUPPL-10 Novo Labeling Approved
Ryzodeg 70/30
NDA #203313
Insulin Aspart; Insulin Degludec Solution; Subcutaneous SUPPL-10 Novo Labeling Approved
Soliqua 100/33
NDA #208673
Insulin Glargine; Lixisenatide Solution; Subcutaneous SUPPL-8 Sanofi-Aventis Us Labeling Approved
Soliqua 100/33
NDA #208673
Insulin Glargine; Lixisenatide Solution; Subcutaneous SUPPL-9 Sanofi-Aventis Us Labeling Approved
Soliqua 100/33
NDA #208673
Insulin Glargine; Lixisenatide Solution; Subcutaneous SUPPL-8 Sanofi-Aventis Us Labeling Approved
Soliqua 100/33
NDA #208673
Insulin Glargine; Lixisenatide Solution; Subcutaneous SUPPL-9 Sanofi-Aventis Us Labeling Approved
Toujeo Max Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-13 Sanofi Us Services Labeling Approved
Toujeo Max Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-13 Sanofi Us Services Labeling Approved
Toujeo Max Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-14 Sanofi Us Services Labeling Approved
Toujeo Max Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-14 Sanofi Us Services Labeling Approved
Toujeo Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-13 Sanofi Us Services Labeling Approved
Toujeo Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-13 Sanofi Us Services Labeling Approved
Toujeo Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-14 Sanofi Us Services Labeling Approved
Toujeo Solostar
NDA #206538
Insulin Glargine Recombinant Solution; Subcutaneous SUPPL-14 Sanofi Us Services Labeling Approved
Tresiba
NDA #203314
Insulin Degludec Solution; Subcutaneous SUPPL-15 Novo Labeling Approved
Tresiba
NDA #203314
Insulin Degludec Solution; Subcutaneous SUPPL-15 Novo Labeling Approved
Tresiba
NDA #203314
Insulin Degludec Solution; Subcutaneous SUPPL-16 Novo Labeling Approved
Vosevi
NDA #209195
Sofosbuvir; Velpatasvir; Voxilaprevir Tablet; Oral SUPPL-3 Gilead Sciences Inc Efficacy Approved
Xarelto
NDA #022406
Rivaroxaban Tablet; Oral SUPPL-27 Janssen Pharms Labeling Approved
Xarelto
NDA #202439
Rivaroxaban Tablet; Oral SUPPL-34 Janssen Pharms Labeling Approved
Xultophy 100/3.6
NDA #208583
Insulin Degludec; Liraglutide Solution; Subcutaneous SUPPL-14 Novo Labeling Approved
Xultophy 100/3.6
NDA #208583
Insulin Degludec; Liraglutide Solution; Subcutaneous SUPPL-15 Novo Labeling Approved
Xultophy 100/3.6
NDA #208583
Insulin Degludec; Liraglutide Solution; Subcutaneous SUPPL-14 Novo Labeling Approved
Xultophy 100/3.6
NDA #208583
Insulin Degludec; Liraglutide Solution; Subcutaneous SUPPL-15 Novo Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-23 Teva Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-24 Teva Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-17 Teva Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-19 Teva Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-21 Teva Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-23 Teva Labeling Approved
Zolpidem Tartrate
ANDA #076410
Zolpidem Tartrate Tablet; Oral SUPPL-24 Teva Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-5 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-6 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-7 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-2 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-3 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-4 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-5 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-6 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #200266
Zolpidem Tartrate Tablet, Extended Release; Oral SUPPL-7 Apotex Inc Labeling Approved
Zolpidem Tartrate
ANDA #201509
Zolpidem Tartrate Tablet; Sublingual SUPPL-1 Par Form Labeling Approved
Zolpidem Tartrate
ANDA #201509
Zolpidem Tartrate Tablet; Sublingual SUPPL-1 Par Form Labeling Approved
Zolpidem Tartrate
ANDA #201509
Zolpidem Tartrate Tablet; Sublingual SUPPL-2 Par Form Labeling Approved

November 14, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Brukinsa
NDA #213217
Zanubrutinib Capsule; Oral ORIG-1 Beigene Usa Inc Type 1 - New Molecular Entity Approved
Buspirone Hydrochloride
ANDA #210907
Buspirone Hydrochloride Tablet; Oral ORIG-1 Unichem Labs Ltd Approved
Celecoxib
ANDA #208701
Celecoxib Capsule; Oral ORIG-1 Cadila Pharms Ltd Approved
Clobetasol Propionate
ANDA #077763
Clobetasol Propionate Aerosol, Foam; Topical SUPPL-11 Perrigo Israel Labeling Approved
Clobetasol Propionate
ANDA #077763
Clobetasol Propionate Aerosol, Foam; Topical SUPPL-13 Perrigo Israel Labeling Approved
Clobetasol Propionate (Emollient)
ANDA #075633
Clobetasol Propionate Cream; Topical SUPPL-10 Taro Labeling Approved
Didanosine
ANDA #090094
Didanosine Capsule, Delayed Rel Pellets; Oral SUPPL-13 Aurobindo Pharma Labeling Approved
Didanosine
ANDA #090094
Didanosine Capsule, Delayed Rel Pellets; Oral SUPPL-14 Aurobindo Pharma Labeling Approved
Didanosine
ANDA #090094
Didanosine Capsule, Delayed Rel Pellets; Oral SUPPL-13 Aurobindo Pharma Labeling Approved
Didanosine
ANDA #090094
Didanosine Capsule, Delayed Rel Pellets; Oral SUPPL-14 Aurobindo Pharma Labeling Approved
Doxercalciferol
ANDA #203875
Doxercalciferol Injectable; Injection ORIG-1 Sun Pharm Approved
Emend
NDA #021549
Aprepitant Capsule; Oral SUPPL-30 Merck Labeling Approved
Emend
NDA #022023
Fosaprepitant Dimeglumine Powder; Intravenous SUPPL-19 Merck and Co Inc Labeling Approved
Emend
NDA #207865
Aprepitant For Suspension; Oral SUPPL-3 Msd Merck Co Labeling Approved
Fetroja
NDA #209445
Cefiderocol Sulfate Tosylate Powder; Intravenous ORIG-1 Shionogi Inc Type 1 - New Molecular Entity Approved
Fluticasone Propionate
ANDA #077570
Fluticasone Propionate Spray, Metered; Nasal SUPPL-13 Hi Tech Pharma Labeling Approved
Fluticasone Propionate
ANDA #077570
Fluticasone Propionate Spray, Metered; Nasal SUPPL-13 Hi Tech Pharma Labeling Approved
Fluticasone Propionate
ANDA #090759
Fluticasone Propionate Lotion; Topical SUPPL-5 Glenmark Generics Labeling Approved
Fluticasone Propionate
ANDA #090759
Fluticasone Propionate Lotion; Topical SUPPL-3 Glenmark Generics Labeling Approved
Fluticasone Propionate
ANDA #090759
Fluticasone Propionate Lotion; Topical SUPPL-5 Glenmark Generics Labeling Approved
Furosemide
ANDA #202747
Furosemide Injectable; Injection SUPPL-3 Baxter Hlthcare Corp Labeling Approved
Gemcitabine Hydrochloride
ANDA #202063
Gemcitabine Hydrochloride Injectable; Injection SUPPL-9 Emcure Pharms Ltd Labeling Approved
Gemcitabine Hydrochloride
ANDA #202063
Gemcitabine Hydrochloride Injectable; Injection SUPPL-8 Emcure Pharms Ltd Labeling Approved
Gemcitabine Hydrochloride
ANDA #202063
Gemcitabine Hydrochloride Injectable; Injection SUPPL-7 Emcure Pharms Ltd Labeling Approved
Gemcitabine Hydrochloride
ANDA #202063
Gemcitabine Hydrochloride Injectable; Injection SUPPL-8 Emcure Pharms Ltd Labeling Approved
Hysingla Er
NDA #206627
Hydrocodone Bitartrate Tablet, Extended Release; Oral SUPPL-9 Purdue Pharma Lp REMS Approved
Metformin Hydrochloride
ANDA #075969
Metformin Hydrochloride Tablet; Oral SUPPL-11 Mylan Pharms Inc Labeling Approved
Metformin Hydrochloride
ANDA #075969
Metformin Hydrochloride Tablet; Oral SUPPL-12 Mylan Pharms Inc Labeling Approved
Metformin Hydrochloride
ANDA #075969
Metformin Hydrochloride Tablet; Oral SUPPL-11 Mylan Pharms Inc Labeling Approved
Metformin Hydrochloride
ANDA #075969
Metformin Hydrochloride Tablet; Oral SUPPL-12 Mylan Pharms Inc Labeling Approved
Metformin Hydrochloride
ANDA #075976
Metformin Hydrochloride Tablet; Oral SUPPL-20 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #075976
Metformin Hydrochloride Tablet; Oral SUPPL-21 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #075976
Metformin Hydrochloride Tablet; Oral SUPPL-20 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #075976
Metformin Hydrochloride Tablet; Oral SUPPL-21 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #076650
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-7 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #076650
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #076650
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-7 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #076650
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #077113
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #077113
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-9 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #077113
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-9 Mylan Labeling Approved
Metformin Hydrochloride
ANDA #209303
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-2 Alignscience Pharma Labeling Approved
Methamphetamine Hydrochloride
ANDA #091189
Methamphetamine Hydrochloride Tablet; Oral SUPPL-6 Mayne Pharma Inc Labeling Approved
Methamphetamine Hydrochloride
ANDA #091189
Methamphetamine Hydrochloride Tablet; Oral SUPPL-5 Mayne Pharma Inc Labeling Approved
Methamphetamine Hydrochloride
ANDA #091189
Methamphetamine Hydrochloride Tablet; Oral SUPPL-4 Mayne Pharma Inc Labeling Approved
Methamphetamine Hydrochloride
ANDA #091189
Methamphetamine Hydrochloride Tablet; Oral SUPPL-5 Mayne Pharma Inc Labeling Approved
Methamphetamine Hydrochloride
ANDA #091189
Methamphetamine Hydrochloride Tablet; Oral SUPPL-6 Mayne Pharma Inc Labeling Approved
Miglustat
ANDA #208342
Miglustat Capsule; Oral SUPPL-1 Amerigen Pharms Ltd Labeling Approved
Oxycontin
NDA #022272
Oxycodone Hydrochloride Tablet, Extended Release; Oral SUPPL-42 Purdue Pharma Lp REMS Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-11 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-11 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-13 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-14 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-11 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-13 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-14 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #077619
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Dr Reddys Labs Ltd Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-16 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-22 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-16 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-19 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #090074
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-22 Torrent Pharms Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-13 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-10 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-12 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-13 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-15 Aurobindo Pharma Ltd Labeling Approved
Pantoprazole Sodium
ANDA #202038
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-18 Aurobindo Pharma Ltd Labeling Approved
Propafenone Hydrochloride
ANDA #205956
Propafenone Hydrochloride Capsule, Extended Release; Oral SUPPL-3 Wilshire Pharms Inc Labeling Approved
Quetiapine Fumarate
ANDA #090960
Quetiapine Fumarate Tablet; Oral SUPPL-10 Apotex Inc Labeling Approved
Quetiapine Fumarate
ANDA #090960
Quetiapine Fumarate Tablet; Oral SUPPL-10 Apotex Inc Labeling Approved
Quetiapine Fumarate
ANDA #090960
Quetiapine Fumarate Tablet; Oral SUPPL-11 Apotex Inc Labeling Approved
Ropivacaine Hydrochloride
ANDA #206166
Ropivacaine Hydrochloride Solution; Injection SUPPL-3 Inforlife Labeling Approved
Ropivacaine Hydrochloride
ANDA #206166
Ropivacaine Hydrochloride Solution; Injection SUPPL-3 Inforlife Labeling Approved
Spironolactone
ANDA #040424
Spironolactone Tablet; Oral SUPPL-21 Mylan Labeling Approved
Spironolactone
ANDA #203253
Spironolactone Tablet; Oral SUPPL-5 Jubilant Generics Labeling Approved
Temozolomide
ANDA #078879
Temozolomide Capsule; Oral SUPPL-15 Barr Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-2 Ipca Labs Ltd Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-4 Ipca Labs Ltd Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-5 Ipca Labs Ltd Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-1 Ipca Labs Ltd Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-2 Ipca Labs Ltd Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-4 Ipca Labs Ltd Labeling Approved
Warfarin Sodium
ANDA #200104
Warfarin Sodium Tablet; Oral SUPPL-5 Ipca Labs Ltd Labeling Approved

November 13, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Lumason
NDA #203684
Sulfur Hexafluoride Lipid-Type A Microspheres For Suspension; Intravenous SUPPL-5 Bracco Efficacy Approved
Meloxicam
ANDA #077938
Meloxicam Tablet; Oral SUPPL-4 Puracap Pharm Labeling Approved
Midazolam Hydrochloride
ANDA #208878
Midazolam Hydrochloride Injectable; Injection SUPPL-1 Fresenius Kabi Usa Labeling Approved
Midodrine Hydrochloride
ANDA #076449
Midodrine Hydrochloride Tablet; Oral SUPPL-14 Impax Pharms Labeling Approved
Midodrine Hydrochloride
ANDA #077746
Midodrine Hydrochloride Tablet; Oral SUPPL-7 Apotex Labeling Approved
Midodrine Hydrochloride
ANDA #077746
Midodrine Hydrochloride Tablet; Oral SUPPL-7 Apotex Labeling Approved
Orvaten
ANDA #076725
Midodrine Hydrochloride Tablet; Oral SUPPL-17 Upsher Smith Labs Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-5 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-6 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-7 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-5 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-6 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-7 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-8 Rubicon Labeling Approved
Pantoprazole Sodium
ANDA #090807
Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-9 Rubicon Labeling Approved
Procainamide Hydrochloride
ANDA #088636
Procainamide Hydrochloride Injectable; Injection SUPPL-15 Intl Medication Labeling Approved
Propafenone Hydrochloride
ANDA #075203
Propafenone Hydrochloride Tablet; Oral SUPPL-17 Watson Labs Labeling Approved
Propafenone Hydrochloride
ANDA #075203
Propafenone Hydrochloride Tablet; Oral SUPPL-17 Watson Labs Labeling Approved
Propafenone Hydrochloride
ANDA #202445
Propafenone Hydrochloride Tablet; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Propafenone Hydrochloride
ANDA #202445
Propafenone Hydrochloride Tablet; Oral SUPPL-1 Aurobindo Pharma Ltd Labeling Approved

November 12, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Daptomycin
ANDA #091039
Daptomycin Powder; Intravenous SUPPL-2 Teva Pharms Usa Labeling Approved
Daptomycin
ANDA #091039
Daptomycin Powder; Intravenous SUPPL-3 Teva Pharms Usa Labeling Approved
Daptomycin
ANDA #091039
Daptomycin Powder; Intravenous SUPPL-4 Teva Pharms Usa Labeling Approved
Eszopiclone
ANDA #091166
Eszopiclone Tablet; Oral SUPPL-4 Glenmark Generics Labeling Approved
Eszopiclone
ANDA #091166
Eszopiclone Tablet; Oral SUPPL-5 Glenmark Generics Labeling Approved
Eszopiclone
ANDA #091166
Eszopiclone Tablet; Oral SUPPL-4 Glenmark Generics Labeling Approved
Eszopiclone
ANDA #091166
Eszopiclone Tablet; Oral SUPPL-5 Glenmark Generics Labeling Approved
Eszopiclone
ANDA #091166
Eszopiclone Tablet; Oral SUPPL-6 Glenmark Generics Labeling Approved
Indomethacin
ANDA #070673
Indomethacin Capsule; Oral SUPPL-20 Sandoz Labeling Approved
Indomethacin
ANDA #070673
Indomethacin Capsule; Oral SUPPL-21 Sandoz Labeling Approved
Indomethacin
ANDA #070674
Indomethacin Capsule; Oral SUPPL-20 Sandoz Labeling Approved
Indomethacin
ANDA #070674
Indomethacin Capsule; Oral SUPPL-21 Sandoz Labeling Approved
Itraconazole
ANDA #205724
Itraconazole Capsule; Oral SUPPL-1 Par Pharm Inc Labeling Approved
Itraconazole
ANDA #205724
Itraconazole Capsule; Oral SUPPL-2 Par Pharm Inc Labeling Approved
Itraconazole
ANDA #205724
Itraconazole Capsule; Oral SUPPL-4 Par Pharm Inc Labeling Approved
Itraconazole
ANDA #205724
Itraconazole Capsule; Oral SUPPL-1 Par Pharm Inc Labeling Approved
Itraconazole
ANDA #205724
Itraconazole Capsule; Oral SUPPL-4 Par Pharm Inc Labeling Approved
Risperidone
ANDA #078871
Risperidone Tablet; Oral SUPPL-5 Celltrion Labeling Approved
Risperidone
ANDA #078871
Risperidone Tablet; Oral SUPPL-6 Celltrion Labeling Approved
Risperidone
ANDA #078871
Risperidone Tablet; Oral SUPPL-7 Celltrion Labeling Approved
Risperidone
ANDA #201003
Risperidone Tablet; Oral SUPPL-10 Ajanta Pharma Ltd Labeling Approved
Risperidone
ANDA #201003
Risperidone Tablet; Oral SUPPL-14 Ajanta Pharma Ltd Labeling Approved
Risperidone
ANDA #201003
Risperidone Tablet; Oral SUPPL-16 Ajanta Pharma Ltd Labeling Approved

November 8, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Adapalene and Benzoyl Peroxide
ANDA #208108
Adapalene; Benzoyl Peroxide Gel; Topical ORIG-1 Glenmark Pharms Ltd Approved
Bendeka
NDA #208194
Bendamustine Hydrochloride Solution; Iv (Infusion) SUPPL-20 Eagle Pharms Labeling Approved
Dorzolamide Hydrochloride
ANDA #204778
Dorzolamide Hydrochloride Solution/Drops; Ophthalmic ORIG-1 Micro Labs Approved
Famotidine
ANDA #075610
Famotidine Tablet; Oral SUPPL-9 Apotex Labeling Approved
Famotidine
ANDA #075610
Famotidine Tablet; Oral SUPPL-9 Apotex Labeling Approved
Famotidine
ANDA #075610
Famotidine Tablet; Oral SUPPL-10 Apotex Labeling Approved
Famotidine
ANDA #077367
Famotidine Tablet; Oral SUPPL-17 Dr Reddys Labs Ltd Labeling Approved
Metformin Hydrochloride
ANDA #076873
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Sandoz Labeling Approved
Metformin Hydrochloride
ANDA #076873
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-9 Sandoz Labeling Approved
Metformin Hydrochloride
ANDA #076873
Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-8 Sandoz Labeling Approved
Metronidazole In Plastic Container
ANDA #078084
Metronidazole Injectable; Injection SUPPL-11 Baxter Hlthcare Corp Labeling Approved
Metronidazole In Plastic Container
ANDA #078084
Metronidazole Injectable; Injection SUPPL-14 Baxter Hlthcare Corp Labeling Approved
Montelukast Sodium
ANDA #090955
Montelukast Sodium Granule; Oral SUPPL-10 Teva Pharms Labeling Approved
Montelukast Sodium
ANDA #090955
Montelukast Sodium Granule; Oral SUPPL-12 Teva Pharms Labeling Approved
Montelukast Sodium
ANDA #090955
Montelukast Sodium Granule; Oral SUPPL-13 Teva Pharms Labeling Approved
Montelukast Sodium
ANDA #090955
Montelukast Sodium Granule; Oral SUPPL-12 Teva Pharms Labeling Approved
Montelukast Sodium
ANDA #090955
Montelukast Sodium Granule; Oral SUPPL-13 Teva Pharms Labeling Approved
Montelukast Sodium
ANDA #203328
Montelukast Sodium Tablet, Chewable; Oral SUPPL-1 Ajanta Pharma Ltd Labeling Approved
Montelukast Sodium
ANDA #203328
Montelukast Sodium Tablet, Chewable; Oral SUPPL-7 Ajanta Pharma Ltd Labeling Approved
Montelukast Sodium
ANDA #203328
Montelukast Sodium Tablet, Chewable; Oral SUPPL-8 Ajanta Pharma Ltd Labeling Approved
Montelukast Sodium
ANDA #203432
Montelukast Sodium Tablet; Oral SUPPL-1 Ajanta Pharma Ltd Labeling Approved
Montelukast Sodium
ANDA #203432
Montelukast Sodium Tablet; Oral SUPPL-5 Ajanta Pharma Ltd Labeling Approved
Montelukast Sodium
ANDA #203432
Montelukast Sodium Tablet; Oral SUPPL-7 Ajanta Pharma Ltd Labeling Approved
Montelukast Sodium
ANDA #203432
Montelukast Sodium Tablet; Oral SUPPL-1 Ajanta Pharma Ltd Labeling Approved
Montelukast Sodium
ANDA #203432
Montelukast Sodium Tablet; Oral SUPPL-5 Ajanta Pharma Ltd Labeling Approved
Montelukast Sodium
ANDA #203432
Montelukast Sodium Tablet; Oral SUPPL-7 Ajanta Pharma Ltd Labeling Approved
Montelukast Sodium
ANDA #203438
Montelukast Sodium Granule; Oral SUPPL-1 Ajanta Pharma Ltd Labeling Approved
Montelukast Sodium
ANDA #203438
Montelukast Sodium Granule; Oral SUPPL-6 Ajanta Pharma Ltd Labeling Approved
Montelukast Sodium
ANDA #203438
Montelukast Sodium Granule; Oral SUPPL-10 Ajanta Pharma Ltd Labeling Approved
Propofol
ANDA #205307
Propofol Injectable; Injection SUPPL-1 Watson Labs Inc Labeling Approved
Provocholine
NDA #019193
Methacholine Chloride For Solution; Inhalation SUPPL-21 Methapharm Efficacy Approved
Reblozyl
BLA #761136
Luspatercept-Aamt Powder; Subcutaneous ORIG-1 Celgene Corp Type 1 - New Molecular Entity Approved
Supprelin La
NDA #022058
Histrelin Acetate Implant; Subcutaneous SUPPL-16 Endo Pharm Labeling Approved

November 7, 2019

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Absorica
NDA #021951
Isotretinoin Capsule; Oral SUPPL-13 Sun Pharm Inds Inc Labeling Approved
Allopurinol
ANDA #075798
Allopurinol Tablet; Oral SUPPL-21 Vintage Pharms Labeling Approved
Atorvastatin Calcium
ANDA #205945
Atorvastatin Calcium Tablet; Oral ORIG-1 Micro Labs Ltd India Approved
Atovaquone
ANDA #207833
Atovaquone Suspension; Oral SUPPL-1 Paddock Llc Labeling Approved
Atovaquone
ANDA #207833
Atovaquone Suspension; Oral SUPPL-2 Paddock Llc Labeling Approved
Benazepril Hydrochloride and Hydrochlorothiazide
ANDA #077483
Benazepril Hydrochloride; Hydrochlorothiazide Tablet; Oral SUPPL-9 Sun Pharm Inds Ltd Labeling Approved
Benazepril Hydrochloride and Hydrochlorothiazide
ANDA #077483
Benazepril Hydrochloride; Hydrochlorothiazide Tablet; Oral SUPPL-10 Sun Pharm Inds Ltd Labeling Approved
Benznidazole
NDA #209570
Benznidazole Tablet; Oral SUPPL-1 Chemo Research Sl Labeling Approved
Bortezomib
ANDA #208460
Bortezomib Injectable; Injection ORIG-1 Hospira Inc Tentative Approval
Children's Claritin
NDA #021891
Loratadine Tablet, Chewable; Oral SUPPL-32 Bayer Healthcare Llc Manufacturing (CMC) Approved
Claritin
NDA #021891
Loratadine Tablet, Chewable; Oral SUPPL-32 Bayer Healthcare Llc Manufacturing (CMC) Approved
Diflucan In Dextrose 5% In Plastic Container
NDA #019950
Fluconazole Injectable; Injection SUPPL-66 Pfizer Labeling Approved
Diflucan In Dextrose 5% In Plastic Container
NDA #019950
Fluconazole Injectable; Injection SUPPL-67 Pfizer Labeling Approved
Diflucan In Sodium Chloride 0.9%
NDA #019950
Fluconazole Injectable; Injection SUPPL-66 Pfizer Labeling Approved
Diflucan In Sodium Chloride 0.9%
NDA #019950
Fluconazole Injectable; Injection SUPPL-67 Pfizer Labeling Approved
Diflucan In Sodium Chloride 0.9% In Plastic Container
NDA #019950
Fluconazole Injectable; Injection SUPPL-66 Pfizer Labeling Approved
Diflucan In Sodium Chloride 0.9% In Plastic Container
NDA #019950
Fluconazole Injectable; Injection SUPPL-67 Pfizer Labeling Approved
Eszopiclone
ANDA #091169
Eszopiclone Tablet; Oral SUPPL-7 Teva Labeling Approved
Eszopiclone
ANDA #091169
Eszopiclone Tablet; Oral SUPPL-8 Teva Labeling Approved
Eszopiclone
ANDA #091169
Eszopiclone Tablet; Oral SUPPL-10 Teva Labeling Approved
Eszopiclone
ANDA #091169
Eszopiclone Tablet; Oral SUPPL-3 Teva Labeling Approved
Eszopiclone
ANDA #091169
Eszopiclone Tablet; Oral SUPPL-7 Teva Labeling Approved
Eszopiclone
ANDA #091169
Eszopiclone Tablet; Oral SUPPL-8 Teva Labeling Approved
Eszopiclone
ANDA #091169
Eszopiclone Tablet; Oral SUPPL-10 Teva Labeling Approved
Exem Foam
NDA #212279
Air Polymer-Type A Foam; Intrauterine ORIG-1 Giskit B.V. Type 1 - New Molecular Entity Approved
Hyzaar
NDA #020387
Hydrochlorothiazide; Losartan Potassium Tablet; Oral SUPPL-64 Merck Sharp Dohme Labeling Approved
Montelukast Sodium
ANDA #090926
Montelukast Sodium Tablet; Oral SUPPL-4 Glenmark Generics Labeling Approved
Montelukast Sodium
ANDA #090926
Montelukast Sodium Tablet; Oral SUPPL-6 Glenmark Generics Labeling Approved
Montelukast Sodium
ANDA #090926
Montelukast Sodium Tablet; Oral SUPPL-8 Glenmark Generics Labeling Approved
Montelukast Sodium
ANDA #090926
Montelukast Sodium Tablet; Oral SUPPL-11 Glenmark Generics Labeling Approved
Montelukast Sodium
ANDA #090926
Montelukast Sodium Tablet; Oral SUPPL-6 Glenmark Generics Labeling Approved
Montelukast Sodium
ANDA #202717
Montelukast Sodium Tablet; Oral SUPPL-14 Accord Hlthcare Labeling Approved
Montelukast Sodium
ANDA #202717
Montelukast Sodium Tablet; Oral SUPPL-15 Accord Hlthcare Labeling Approved
Montelukast Sodium
ANDA #202906
Montelukast Sodium Granule; Oral SUPPL-6 Dr Reddys Labs Ltd Labeling Approved
Montelukast Sodium
ANDA #202906
Montelukast Sodium Granule; Oral SUPPL-7 Dr Reddys Labs Ltd Labeling Approved
Montelukast Sodium
ANDA #202906
Montelukast Sodium Granule; Oral SUPPL-10 Dr Reddys Labs Ltd Labeling Approved
Montelukast Sodium
ANDA #202906
Montelukast Sodium Granule; Oral SUPPL-11 Dr Reddys Labs Ltd Labeling Approved
Montelukast Sodium
ANDA #202906
Montelukast Sodium Granule; Oral SUPPL-12 Dr Reddys Labs Ltd Labeling Approved
Montelukast Sodium
ANDA #202906
Montelukast Sodium Granule; Oral SUPPL-10 Dr Reddys Labs Ltd Labeling Approved
Montelukast Sodium
ANDA #202906
Montelukast Sodium Granule; Oral SUPPL-11 Dr Reddys Labs Ltd Labeling Approved
Montelukast Sodium
ANDA #202906
Montelukast Sodium Granule; Oral SUPPL-12 Dr Reddys Labs Ltd Labeling Approved
Stelara
BLA #125261
Ustekinumab Injectable; Injection SUPPL-142 Centocor Ortho Biotech Inc Labeling Approved
Stelara
BLA #761044
Ustekinumab Injectable; Injection SUPPL-1 Janssen Biotech Labeling Approved
Zontivity
NDA #204886
Vorapaxar Sulfate Tablet; Oral SUPPL-5 Toprol Labeling Approved

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