ANDA Approvals - Fall 2019

Robins Kaplan LLP

November, 2019

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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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Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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