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ANDA Approvals

Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
10/1/2018 Pristiq Desvenlafaxine Succinate PF Prism CV Yichang Humanwell
10/2/2018 Inomax Noxivent Mallinckrodt Praxair Distribution
10/3/2018 Aromasin Exemestane Pharmacia and Upjohn Zydus
10/3/2018 Comtan Entacapone Orion Pharma Sunshine Lake
10/3/2018 Daliresp Roflumilast AstraZeneca Breckenridge
10/3/2018 Methylin Methylphenidate HCl Specgx Wes Pharma
10/3/2018 Minipress Prazosin HCl Pfizer Novitium Pharma
10/3/2018 Mirapex Pramipexole Dihydrochloride Boehringer Ingelheim CSPC Ouyi Pharm
10/4/2018 Olux Clobetasol Propionate Mylan Taro Pharm
10/4/2018 Levophed Norepinephrine Bitartrate Hospira Mylan
10/5/2018 Welchol Colesevelam HCl Daiichi Sankyo Alkem
10/5/2018 Kenalog-40 Triamcinolone Acetonide Apothecon Teva
10/5/2018 Welchol Colesevelam HCl Daiichi Sankyo Dr Reddy's Labs
10/9/2018 Latisse Bimatoprost Allergan Hi-Tech Pharmacal
10/9/2018 Zithromax Azithromycin Pfizer Hainan Poly Pharm
10/9/2018 Zemplar Paricalcitol AbbVie Aurobindo
10/9/2018 Tikosyn Dofetilide Pfizer Par
10/9/2018 Zithromax Azithromycin Pfizer Aurobindo
10/9/2018 Focalin XR Dexmethylphenidate HCl Novartis Adare Pharms
10/9/2018 Tikosyn Dofetilide Pfizer Sun
10/9/2018 Suprax Cefixime Lupin Alkem
10/10/2018 Aggrenox Aspirin / Dipyridamole Boehringer Ingelheim Dr Reddy's Labs
10/11/2018 Sensipar Cinacalcet HCl Amgen Sun
10/11/2018 Mepron Atovaquone GlaxoSmithKline Hetero Labs
10/12/2018 Viagra Sildenafil Citrate Pfizer Ajanta
10/12/2018 Omeprazole Omeprazole (OTC) Dexcel Pharma Sun
10/12/2018 Glucophage Metformin HCl Bristol-Myers Squibb Sunshine Lake
10/12/2018 Betamethasone Dipropionate Betamethasone Dipropionate Fougera Pharms G and W Labs
10/12/2018 Depo-Provera Medroxyprogesterone Acetate Pharmacia and Upjohn Mylan
10/12/2018 Kapvay Clonidine HCl Concordia Pharms Upsher-Smith Labs
10/16/2018 Sensipar Cinacalcet HCl Amgen Mylan
10/16/2018 Rilutek Riluzole Covis Pharma Daito Pharms
10/16/2018 Eloxatin Oxaliplatin Sanofi Aventis / Teva Ingenus Pharms
10/16/2018 Crestor Rosuvastatin Calcium IPR Amneal
10/16/2018 BICNU Carmustine Emcure Pharms Amneal
10/16/2018 Actigall Ursodiol Allergan Amneal
10/16/2018 Cymbalta Duloxetine HCl Eli Lilly CSPC Ouyi Pharm
10/16/2018 Neurontin Gabapentin Eli Lilly Strides
10/16/2018 Wellbutrin SR Bupropion HCl GlaxoSmithKline Yichang Humanwell
10/16/2018 Fluocinonide Fluocinonide Taro Teligent Pharma
10/17/2018 Prevacid Lansoprazole Takeda Breckenridge
10/17/2018 Epiduo Forte Adapalene / Benzoyl Peroxide Galderma Labs Taro
10/17/2018 Isuprel Isoproterenol HCl Hospira Amneal
10/18/2018 Capastat Sulfate Capreomycin Sulfate Akorn Hisun Pharm Hangzhou
10/18/2018 Diamox Acetazolamide Teva Accord Healthcare
10/18/2018 Levophed Norepinephrine Bitartrate Hospira Sandoz
10/22/2018 Glucophage XR Metformin HCl Bristol-Myers Squibb Alkem
10/22/2018 Onfi Clobazam Lundbeck West-Ward Pharms
10/22/2018 Onfi Clobazam Lundbeck Bionpharma
10/22/2018 Onfi Clobazam Lundbeck Breckenridge
10/22/2018 Onfi Clobazam Lundbeck Taro Pharm
10/22/2018 Onfi Clobazam Lundbeck Upsher-Smith Labs
10/22/2018 Onfi Clobazam Lundbeck West-Ward Pharms
10/22/2018 Onfi Clobazam Lundbeck Amneal
10/22/2018 Onfi Clobazam Lundbeck Hetero Labs
10/22/2018 Onfi Clobazam Lundbeck Piramal
10/22/2018 Onfi Clobazam Lundbeck Upsher-Smith Labs
10/22/2018 Onfi Clobazam Lundbeck Mylan
10/22/2018 Onfi Clobazam Lundbeck Zydus
10/23/2018 Aleve PM Naproxen Sodium / Diphenhydramine Hydrochloride (OTC) Bayer Amneal
10/23/2018 Topicort Desoximetasone Taro Pharm Teligent Pharma
10/24/2018 Ampyra Dalfampridine Acorda West-Ward Pharms
10/25/2018 Zithromax Azithromycin Pfizer CSPC Ouyi Pharm
10/25/2018 Ritalin Methylphenidate HCl Novartis Aurolife Pharma
10/25/2018 Renvela Sevelamer Carbonate Genzyme Dr Reddy's Labs
10/25/2018 Derma-Smoothe/FS Flucinolone Acetonide Hill Dermac Glenmark
10/26/2018 Toprol-XL Metoprolol Succinate Aralez Pharms Cipla
10/26/2018 Aubagio Teriflunomide Sanofi Aventis  Aurobindo
10/26/2018 Derma-Smooth/FS Fluocinonide Acetonide Hill Dermac Glenmark
10/26/2018 Prometrium Progesterone Virtus Pharms Eugia Pharma
10/26/2018 Clobex Clobetasol Propionate Galderma Labs Hi-Tech Pharmacal
10/26/2018 Seroquel XR Quetiapine Fumarate AstraZeneca Amneal
10/26/2018 Robaxin Methocarbamol West-Ward Pharms Gland Pharma
10/26/2018 Cytomel Liothyronine Sodium King Pharms Teva
10/26/2018 Zetia Ezetimibe Merck Sharp & Dome Accord Healthcare
10/30/2018 Urso 250 Ursodiol Allergan Zydus
10/31/2018 Clolar Clofarabine Genzyme Gland Pharma
10/31/2018 Zytiga Abiraterone Acetate Janssen Hikma
10/31/2018 Zytiga Abiraterone Acetate Janssen Teva
10/31/2018 Zytiga Abiraterone Acetate Janssen Mylan
10/31/2018 Zytiga Abiraterone Acetate Janssen Apotex
10/31/2018 Anafranil Clomipramine HCl Specgx Amneal
10/31/2018 Levitra Vardenafil HCl Bayer Zydus
10/31/2018 Levitra Vardenafil HCl Bayer CrossMedika
10/31/2018 Wellbutrin XL Bupropion HCl Valeant Accord Healthcare
10/31/2018 Levitra Vardenafil HCl Bayer Amneal
11/1/2018 Mucinex DM Guaifenesin / Dextromethorphan Hydrobromide (OTC) RB Hlth Ameal
11/1/2018 Hectorol Doxercalciferol Hospira / Sanofi Lupin
11/2/2018 Bentyl Dicyclomine HCl Allergan Renaissance
11/2/2018 Betapace AF Sotalol HCl Covis Pharma Beximco Pharms
11/2/2018 Aubagio Teriflunomide Sanofi Aventis Apotex
11/2/2018 Fortamet Metformin HCl Andrx Labs Novast Labs
11/5/2018 Cleocin Hydrochloride Clindamycin HCl Pharmacia and Upjohn Micro Labs
11/5/2018 Omeprazole Omeprazole (OTC) Dexcel Pharma Dr Reddy's Labs
11/5/2018 Xopenex Levalbuterol HCl Oak Pharms Sun
11/5/2018 Synalar Fluocinolone Acetonide Medimetriks Pharms G and W Labs
11/6/2018 Aloxi Palonosetron HCl Helsinn Healthcare Aurobindo
11/6/2018 Frova Frovatriptan Succinate Endo Pharms Amneal
11/7/2018 Levophed Norepinephrine Bitartrate Hospira Hikma
11/7/2018 Achromycin V Tetracycline HCl Heritage Pharms Breckenridge
11/8/2018 Cytovene Ganciclovir Roche Hainan Poly Pharm
11/9/2018 Atripla Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate Gilead Sciences Teva
11/9/2018 Arimidex Anastrozole ANI Pharms Beijing Yiling
11/9/2018 Valcyte Valganciclovir HCl Roche Cipla
11/9/2018 Tessalon Benzonatate Pfizer Aiping Pharm
11/9/2018 Dacogen Decitabine Otsuka Lupin
11/9/2018 Pulmicort Respules Budesonide AstraZeneca Lupin
11/13/2018 Lomotil Diphenoxylate HCl / Atropine Sulfate GD Searle Bayshore Pharms
11/14/2018 Femara Letrozole Novartis Beijing Yiling
11/14/2018 Arixtra Fondaparinux Sodium Mylan Scinopharm
11/15/2018 Epzicom Abacavir Sulfate / Lamivudine ViiV Healthcare Aurobindo Pharma
11/15/2018 Diprivan Propofol Fresenius Kabi USA Dr Reddy's Labs
11/15/2018 Acular LS Ketorolac Tromethamine Allergan Aurobindo Pharma
11/15/2018 Epzicom Abacavir Sulfate / Lamivudine ViiV Healthcare Zydus
11/15/2018 Aubagio Teriflunomide Sanofi Aventis Glenmark
11/16/2018 Aleve Naproxen Sodium (OTC) Bayer Novelgenix Theraps
11/16/2018 Staxyn Vardenafil HCl Bayer Alembic Pharms
11/16/2018 Zyrtec-D 12 Hour Cetirizine HCl / Pseudoephedrine HCl (OTC) Johnson and Johnson Perrigo
11/16/2018 Anectine / Quelicin Succinylcholine Chloride Sandoz / Hospira Amneal
11/19/2018 Zometa Zoledronic Acid Novartis Dr Reddy's Labs
11/19/2018 Finacea Azelaic Acid Leo Pharma Glenmark
11/19/2018 Zyprexa Olanzapine Eli Lilly Sunshine Lake
11/19/2018 Finacea Azelaic Acid Leo Pharma Actavi
11/19/2018 Finacea Azelaic Acid Leo Pharma Tolmar
11/19/2018 Abreva Docosanol (OTC) GlaxoSmithKline Actavis
11/20/2018 Lialda Mesalamine Shire Mylan
11/20/2018 Butrans Buprenorphine Purdue Pharma Teva
11/20/2018 Lipitor Atorvastatin Calcium Pfizer Zydus
11/20/2018 Sabril Vigabatrin Lundbeck Dr Reddy's Labs
11/20/2018 Xyzal Allergy 24Hr Levocetirizine Dihydrochloride (OTC) Sanofi Aventis Micro Labs
11/21/2018 Anafranil Clomipramine HCl Specgx Lupin
11/21/2018 Voltaren Diclofenac Sodium GlaxoSmithKline Hi-Tech Pharmacal
11/21/2018 Mepron Atovaquone GlaxoSmithKline Glenmark
11/21/2018 Rocaltrol Calcitriol Validus Pharms Invatech Pharma
11/21/2018 Potassium Chloride Potassium Chloride Pharma Res Software Novel Labs
11/21/2018 Fluoxetine HCl Fluoxetine HCl Alvogen Appco Pharma
11/23/2018 Effexor XR Venlafaxine HCl Wyeth Intellipharmaceutics
11/23/2018 Pravachol Pravastatin Sodium Bristol-Myers Squibb Hisun Pharm Hangzhou
11/23/2018 Daliresp Roflumilast AstraZeneca Hetero Labs
11/23/2018 Integrilin Eptifibatide Schering Celerity Pharms
11/23/2018 Potassium Chloride Potassium Chloride Pharma Res Software Epic Pharma
11/23/2018 Children's Motrin Ibuprofen (OTC) Johnson and Johnson Aptapharma
11/23/2018 Restoril Temazepam Specgx  Alembic
11/26/2018 Prevacid Lansoprazole Takeda Zydus
11/27/2018 Viread Tenofovir Disoproxil Fumarate Gilead Sciences Mylan
11/27/2018 Amicar Aminocaproic Acid Clover Pharms Sunny Pharmtech
11/28/2018 Prevacid Lansoprazole Takeda Mylan
11/29/2018 Renvela Sevelamer Carbonate Sanofi Wilshire Pharms
11/29/2018 Precedex Dexmedetomidine HCl Hospira Fresenius Kabi USA
11/29/2018 Mitigare Colchicine Hikm Par
11/29/2018 Lidex Fluocinonide County Line Pharms Encube Ethicals
11/30/2018 Ganirelix Acetate Ganirelix Acetate Organon USA Sun
11/30/2018 Lamictal XR Lamotrigine GlaxoSmithKline Amneal
11/30/2018 Aubagio Teriflunomide Sanofi Aventis Zydus
11/30/2018 Vfend Voriconazole PF Prism CV Hainan Poly Pharm
12/3/2018 Rapaflo Silodosin Allergan Lupin
12/3/2018 Azor Amlodipine / Olmesartan Medoxomil Daiichi Sankyo Sciegen Pharms
12/3/2018 Rapaflo Silodosin Allergan Amneal
12/3/2018 Rapaflo Silodosin Allergan MSN Labs
12/3/2018 Fluoxetine HCl Fluoxetine HCl Alvogen Teva
12/3/2018 Rapaflo Silodosin Allergan Ajanta
12/3/2018 Rapaflo Silodosin Allergan MacLeods
12/4/2018 Fareston Toremifene Citrate Kyowa Kirin Eirgen Pharma
12/4/2018 Atacand Candesartan Cilexetil ANI Pharms Alembic
12/6/2018 Singulair Montelukast Sodium Merck Sharp & Dome Cipla
12/6/2018 Zithromax Azithromycin Pfizer Sunshine Lake
12/6/2018 Progesterone Progesterone Actavis Eugia Pharma
12/7/2018 Lotrel Amlodipine Besylate / Benazepril HCl Novartis Cipla
12/7/2018 Zithromax Azithromycin Pfizer Sunshine Lake
12/7/2018 Zithromax Azithromycin Pfizer Sunshine Lake
12/7/2018 Patanol Olopatadine HCl Novartis Alembic
12/7/2018 Albenza Albendazole Impax Strides Vivimed
12/10/2018 Rapaflo Silodosin Allergan Aurobindo
12/13/2018 Aptensio XR Methylphenidate HCl Rhodes Pharms Actavis
12/14/2018 Albenza Albendazole Impax Labs Zydus
12/14/2018 Onfi Clobazam Lundbeck Lupin
12/14/2018 Heparin Sodium Heparin Sodium West-Ward Pharms Int / Fresenius Kabi USA Nanjing King-Friend
12/14/2018 Dermotic Fluocinonide Acetonide Hill Dermac Glenmark
12/17/2018 Levophed Norepinephrin Bitartrate Hospira Amneal
12/18/2018 Cyanocobalamin Cyanocobalamin Luitpold Vitruvias Therap
12/18/2018 Cyanocobalamin Cyanocobalamin Luitpold Somerset Therapeutics
12/19/2018 Tessalon Benzonatate Pfizer Puracap Pharm
12/19/2018 Mirapex Pramipexole Dihydrochloride Boehringer Ingelheim Unichem Labs
12/19/2018 Toprol-XL Metoprolol Succinate Aralez Pharms Twi
12/19/2018 Klor-Con Potassium Chloride Upsher Smith Labs Aurobindo
12/21/2018 Claritin Loratadine (OTC) Bayer Bionpharma
12/21/2018 Tygacil Tigecycline PF Prism CV Apotex
12/21/2018 Golytely Polyethylene Glycol 3350 and Electrolytes Braintree Strides
12/21/2018 Doryx Doxycycline Hyclate Mayne Pharma Zydus
12/21/2018 Levothyroxine Sodium Levothyroxine Sodium Fresenius Kabi USA Maia Pharms
12/21/2018 Lipitor Atorvastatin Calcium Pfizer The Pharma Network
12/21/2018 Vazculep Phenylephrine HCL West-Ward Pharm Corp / Avadel Legacy Par Sterile
12/26/2018 Gris-PEG Griseofulvin, Ultramicrosize Valeant Sandoz
12/26/2018 Zithromax Azithromycin Pfizer Bionpharma
12/27/2018 Sensipar Cinacalcet HCl Amgen Teva
12/27/2018 Sandostatin Octreotide Acetate Novartis USV North America
12/27/2018 Elidel Pimecrolimus Valeant Actavis
12/27/2018 Fortamet Metformin HCl Andrx Labs Qingdao Baheal
12/27/2018 Clolar Clofarabine Genzyme Hospira
12/28/2018 Aromasin Exemestane Pharmacia and Upjohn Amneal
12/28/2018 Camptosar Irinotecan HCl Pfizer Shilpa Medicare
12/28/2018 Onfi Clobazam Lundbeck Lupin
12/28/2018 Makena Hydroxyprogesterone Caproate Amag Pharma USA Slayback Pharma
12/28/2018 Duac Clindamycin Phosphate / Benzoyl Peroxide Stiefel Zydus
12/31/2018 Rogaine Minoxidil Johnson and Johnson Taro Pharm

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