Drugs@FDA: FDA Approved Drug Products

Recent New and Generic Drug Approvals

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

7 Day Report
14 Day Report

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