ANDA Approvals

November, 2019

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
07/01/2019 Hygroton chlorthalidone Sanofi Aventis Amneal
07/01/2019 Uloric febuxostat Takeda Mylan
07/01/2019 Uloric febuxostat Takeda Alembic
07/01/2019 Uloric febuxostat Takeda Sun Pharm
07/01/2019 Haldol haloperidol Janssen Fresenius Kabi USA
07/01/2019 Omidria ketorolac tromethamine / phenylephrine HCl Omeros Lupin
07/02/2019 Hemabate carboprost tromethamine Pharmacia and Upjohn Dr Reddys
07/02/2019 Ery-Tab erythromycin Arbor Amneal
07/02/2019 Sporanox itraconazole Johnson & Johnson Pii
07/02/2019 MetroGel-Vaginal Gel metronidazole Bausch Perrigo
07/02/2019 Cytotec misoprostol Pfizer Zydus
07/02/2019 Ultram tramadol HCl Johnson & Johnson Polygen Pharms
07/03/2019 Syprine trientine HCl Aton Dr Reddys
07/05/2019 Trilipix fenofibric acid Abbvie TWi
07/05/2019 Fluoxetine HCl fluoxetine HCl Alvogen G and W Labs
07/05/2019 Ranexa ranolazine Gilead Glenmark Pharms
07/08/2019 Effexor XR venlafaxine HCl Pfizer Annora Pharma
07/09/2019 Atelvia risedronate sodium Allergan Sun Pharm
07/10/2019 Zytiga abiraterone acetate Johnson & Johnson MSN Labs
07/10/2019 Onfi clobazam Lundbeck Vistapharm
07/10/2019 Neoral cyclosporine Novartis Apotex
07/10/2019 Lovaza omega-3-acid ethyl esters Glaxo Sofgen Pharms
07/12/2019 Cubicin daptomycin Cubist Accord Healthcare
07/12/2019 Edecrin ethacrynic acid Bausch Agnitio
07/12/2019 Lymphazurin isosulfan blue Mylan Somerset Theraps
07/12/2019 Technescan Mag3 technetium tc 99m mertiatide kit Curium Pharmalucence
07/15/2019 Firazyr icatibant acetate Shire Teva
07/15/2019 Concerta methylphenidate HCl Johnson & Johnson Par
07/16/2019 Cosmegen dactinomycin Recordati Hisun Pharm Hangzhou
07/17/2019 Adderall XR dextroamphetamine saccharate / amphetamine aspartate monohydrate / dextroamphetamine sulfate / amphetamine sulfate Shire Nesher Pharms
07/17/2019 Cyklokapron tranexamic acid Pharmacia and Upjohn Caplin
07/17/2019 Cyklokapron tranexamic acid Pharmacia and Upjohn Apollo Pharms
07/18/2019 Trilipix fenofibric acid Abbvie Graviti Pharms
07/18/2019 Benicar olmesartan medoxomil Daiichi Sankyo Umedica Labs
07/19/2019 Focalin dexmethylphenidate HCl Novartis Alkem
07/19/2019 Lyrica pregabalin Pfizer Teva
07/19/2019 Lyrica pregabalin Pfizer Teva
07/19/2019 Lyrica pregabalin Pfizer Alembic Pharms
07/19/2019 Lyrica pregabalin Pfizer Alkem
07/19/2019 Lyrica pregabalin Pfizer Alkem
07/19/2019 Lyrica pregabalin Pfizer Sciegen Pharms
07/19/2019 Lyrica pregabalin Pfizer MSN Labs
07/19/2019 Lyrica pregabalin Pfizer Dr Reddys
07/19/2019 Lyrica pregabalin Pfizer Amneal
07/19/2019 Lyrica pregabalin Pfizer Rising
07/19/2019 Lyrica pregabalin Pfizer Cipla
07/22/2019 Fanapt iloperidone Vanda Taro Pharm
07/22/2019 Morphine Sulfate morphine sulfate Hikma Upsher Smith Labs
07/22/2019 Rozarem ramelteon Takeda Zydus
07/23/2019 Faslodex fulvestrant Astra-Zeneca Mylan
07/23/2019 Yaz kyra Bayer Sun Pharm
07/24/2019 Mycostatin nystatin Delcor Asset Corp Torrent
07/25/2019 Lotrimin clotrimazole Schering Plough Tasman Pharma
07/25/2019 Trilipix fenofibric acid Abbvie Aurobindo
07/26/2019 Truvada emtricitabine / tenofovir disoproxil fumarate Gilead Laurus Labs
07/26/2019 Nicorette nicotine polacrilex Glaxo Teva
07/29/2019 Zosyn piperacillin / tazobactam Astral Astral
07/30/2019 Gablofen baclofen Piramal Maia Pharms
07/30/2019 Solodyn ER minocycline HCl Bausch Mylan Labs
07/30/2019 Norcuron vecuronium bromide Organon Hikma
07/31/2019 Colcrys colchicine Takeda Teva
08/01/2019 Hiprex methenamine hippurate US Pharma Micro Labs
08/01/2019 Visken pindolol Novartis Bayshore Pharms
08/01/2019 Tasmar tolcapone Bausch Kinedexe
08/02/2019 Sporanox itraconazole Johnson & Johnson Apotex
08/02/2019 Patanol olopatadine HCl Novartis Gland Pharma
08/02/2019 Quelicin succinylcholine chloride Hospira Dr Reddys
08/05/2019 Evekeo amphetamine sulfate Arbor Granules Pharms
08/05/2019 Depakene valproic acid Abbvie Novelgenix Theraps
08/05/2019 Navelbine vinorelbine tartrate Pierre Fabre Medicament Ingenus Pharms
08/06/2019 Hygroton chlorthalidone Sanofi-Aventis Unichem Labs
08/07/2019 Celebrex celecoxib Searle Qingdao Baheal Pharm
08/07/2019 Lovaza omega-3-acid ethyl esters Glaxo Bionpharma
08/08/2019 Aromasin exemestane Pharmacia and Upjohn Mayne Pharma
08/08/2019 Makeena hydroxyprogesterone caproate Amag Aspen
08/08/2019 Reclast zoledronic acid Novartis Gland Pharma
08/09/2019 Trusopt dorzolamide HCl Merck Alembic
08/09/2019 Tricor fenofibrate Abbvie Alembic
08/09/2019 Makeena hydroxyprogesterone caproate Amag Am Regent
08/09/2019 Keppra levetiracetam UCB Micro Labs
08/09/2019 Ultram tramadol HCl J&J Unichem Labs
08/12/2019 Halog halcinonide Sun Mylan
08/12/2019 Combivir lamivudine / zidovudine Glaxo Mylan
08/13/2019 Toviaz fesoterodine fumarate Pfizer Dr Reddys
08/13/2019 Salagen pilocarpine HCl Eisai Aurobindo 
08/13/2019 Zemuron rocuronium bromide Organon Camargo Pharm
08/14/2019 Brevibloc esmolol hydrochloride Baxter Gland Pharma
08/14/2019 Carnitor levocarnitine Leadiant Biosciences Novitium Pharma
08/14/2019 Carnitor SF levocarnitine sugar free Leadiant Biosciences Novitium Pharma
08/15/2019 Westcort hydrocortisone valerate Sun Lupin
08/15/2019 Percocet oxycodone / acetaminophen Vintage Pharma Halo Pharm
08/16/2019 Cymbalta duloxetine HCl Eli Lilly Yaopharma
08/16/2019 Fusilev levoleucovorin calcium Spectrum Nanjing King-Friend
08/16/2019 Merrem meropenem Astra-Zeneca HQ Specialty Pharma
08/16/2019 Torisel temsirolimus Pfizer Gland Pharma
08/19/2019 Acanya clindamycin phosphate / benzoyl peroxide Bausch Taro
08/19/2019 Acanya clindamycin phosphate / benzoyl peroxide Bausch Tolmar
08/19/2019 Proamatine midodrine HCl Shire Rubicon
08/19/2019 Protonix IV pantoprazole sodium Wyeth Sun Pharm
08/19/2019 Ranexa ranolazine Gilead Zydus
08/19/2019 Zioptan tafluprost Santen Micro Labs
08/19/2019 Detrol LA tolterodine tartrate Pharmacia and Upjohn Inventia Healthcare
08/19/2019 Dyrenium triamterene Concordia Agnitio
08/20/2019 Kuvan Powder sapropterin dihydrochloride Biomarin Par
08/20/2019 Kuvan Tablet sapropterin dihydrochloride Biomarin Par
08/21/2019 Solodyn ER minocycline HCl Bausch Aurobindo
08/21/2019 Solodyn ER minocycline HCl Bausch Mylan
08/21/2019 Noxafil posaconazole Merck Sinotherapeutics
08/22/2019 Cubicin daptomycin Cubist Jiangsu Hengrui Med
08/22/2019 Faslodex fulvestrant Astra-Zeneca Sagent
08/22/2019 Faslodex fulvestrant Astra-Zeneca Glenmark
08/22/2019 Fusilev levoleucovorin calcium Spectrum Nanjing King-Friend
08/22/2019 Methadose methadone HCl SPECGX Pharm Assoc
08/22/2019 Aleve PM naproxen sodium / diphenhydramine HCl Bayer Apotex
08/23/2019 Amicar aminocaproic acid Clover Amneal
08/23/2019 Finacea azelaic acid Leo Taro
08/23/2019 Astepro azelastine HCl Mylan Hi Tech (Akorn)
08/26/2019 Orfadin nitisinone Sobi Novitium Pharma
08/27/2019 Edecrin ethacrynic acid Bausch Sciegen Pharms
08/27/2019 Vesicare solifenacin succinate Astellas Unichem Labs 
08/28/2019 Dacogen decitabine Otsuka MSN Labs
08/29/2019 Elidel pimecrolimus Bausch Glenmark
08/29/2019 Effexor XR venlafaxine HCl Pfizer Cadila Pharms
08/30/2019 Relafen nabumetone SKB Nexgen Pharma
08/30/2019 Aleve naproxen sodium Bayer Yichang Humanwell
08/30/2019 Folxin OTIC ofloxacin Daiichi Sankyo Amneal
08/30/2019 Zantac 150 ranitidine HCl Sanofi Aventis Unique Pharm Labs
08/30/2019 Zantac 75 ranitidine HCl Sanofi Aventis Unique Pharm Labs
09/03/2019 Xalatan latanoprost Pharmacia and Upjohn Aurobindo
09/03/2019 Concerta methylphenidate HCl Johnson & Johnson Ascent Pharms
09/04/2019 Latuda lurasidone HCl Sunovion Emcure Pharms
09/05/2019 Wellbutrin XL bupropion HCl Valeant Zhejiang Jutai Pharma
09/05/2019 Emend I.V. fosaprepitant dimeglumine Merck Mylan
09/05/2019 Emend I.V. fosaprepitant dimeglumine Merck Apotex
09/05/2019 Emend I.V. fosaprepitant dimeglumine Merck MSN Labs
09/05/2019 Emend I.V. fosaprepitant dimeglumine Merck Lupin
09/05/2019 Emend I.V. fosaprepitant dimeglumine Merck Sungen Pharma
09/05/2019 Emend I.V. fosaprepitant dimeglumine Merck Baxter Healthcare
09/05/2019 Emend I.V. fosaprepitant dimeglumine Merck Be Pharms
09/06/2019 Zovirax acyclovir Bausch Health Apotex
09/06/2019 Proventil albuterol sulfate Schering Quagen
09/06/2019 Onfi clobazam Lundbeck Alkem
09/06/2019 Colcrys colchicine Takeda Dr Reddys
09/06/2019 Edecrin ethacrynic acid Bausch Lupin
09/06/2019 Tricor fenofibrate Abbvie Appco Pharma
09/06/2019 Nicorette nicotine polacrilex Glaxo P and L Dev
09/09/2019 Kyprolis carfilzomib Onyx Dr Reddys
09/09/2019 Acanya clindamycin phosphate / benzoyl peroxide Bausch Perrigo
09/09/2019 Olux-E foam clobetasol propionate Mylan Glenmark
09/10/2019 Tylenol w/ Codeine acetaminophen / codeine phosphate Janssen Elite Labs
09/11/2019 Lioresal baclofen Saol Therapeutics Maia Pharms
09/12/2019 Parafon Forte chlorzoxazone Janssen Novitium Pharma
09/13/2019 Sinequan doxepin HCl Pfizer Ajanta
09/13/2019 Soolantra ivermectin Galderma Teva
09/13/2019 Alkeran melphalan hydrochloride Apotex Noratech Pharma
09/13/2019 Corgard nadolol US Worldmeds Vgyaan Pharma
09/16/2019 Lotronex alosetron HCl Sebela Eywa Pharma
09/16/2019 Colcrys colchicine Takeda Mylan
09/16/2019 Dacogen decitabine Otsuka Ingenus Pharms
09/16/2019 Syprine trientine HCl Aton Kadmon Pharms
09/17/2019 Benicar olmesartan medoxomil Daiichi Sankyo Micro Labs
09/17/2019 Benicar HCT olmesartan medoxomil / hydrochlorothiazide Daiichi Sankyo Umedica Labs
09/20/2019 Lyrica pregabalin Pfizer Mylan
09/20/2019 Zomig-ZMT zolmitriptan Astra-Zeneca Mylan
09/23/2019 Invega paliperidone Janssen Amneal
09/23/2019 Androgel 1.62% testosterone Unimed Twi
09/24/2019 Clobex clobetasol propionate Galderma Zydus
09/24/2019 Remodulin treprostinil United Therapeutics Par
09/25/2019 Baraclude entecavir Bristol Myers Squibb Brightgene Bio-Medical Tech
09/25/2019 Syprine trientine HCl Aton Par
09/26/2019 Hectorol doxercalciferol Genzyme Gland Pharma
09/26/2019 Patanol olopatadine HCl Novartis FDC
09/26/2019 Prilosec omeprazole Astra-Zeneca Hetero Labs
09/26/2019 Vesicare solifenacin succinate Astellas Strides Pharma
09/26/2019 Remodulin treprostinil United Therapeutics Teva
09/27/2019 Zytiga abiraterone acetate Johnson & Johnson Qilu Pharm
09/27/2019 Tikosyn dofetilide Pfizer Wilshire Pharms
09/30/2019 Dilantin extended phenytoin sodium Parke-Davis Lupin
09/30/2019 Robinul glycopyrrolate Hikma Gland Pharma
09/30/2019 Potassium Chloride potassium chloride Merck Yichang Humanwell
09/30/2019 Lyrica pregabalin Pfizer Hainan Shuangcheng Pharma
09/30/2019 Lyrica pregabalin Pfizer Alkem
09/30/2019 Viibryd vilazodone HCl Allergan Teva
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