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ANDA Approvals
Summer 2018
Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
---|---|---|---|---|
4/5/2018 | Loprox | Ciclopirox | Medicis | Teligent Pharma |
4/6/2018 | Invega | Paliperidone | Janssen | Sun Pharma |
4/6/2018 | Zovirax | Acyclovir | Valeant | Alembic |
4/9/2018 | Fazaclo ODT | Clozapine | Jazz | Barr Labs |
4/9/2018 | Diovan | Valsartan | Novartis | Square Pharms |
4/9/2018 | Truvada | Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Mylan |
4/9/2018 | Zithromax | Azithromycin | Pfizer | Epic Pharma |
4/9/2018 | Miralax | Polyethylene Glycol 3350 (OTC) | Bayer | Aurobindo |
4/11/2018 | Cubicin | Daptomycin | Cubist Pharms | Fresenius Kabi USA |
4/11/2018 | Atacand HCT | Candesartan Cilexetil and Hydrochlorothiazide | ANI Pharms | Prinston |
4/11/2018 | Dopamine HCl | Dopamine HCl | Hospira | Hikma |
4/11/2018 | Claritin / Claritin Hives Relief | Loratadine (OTC) | Bayer | Aurobindo |
4/11/2018 | Dermotic | Flac | Hill Dermac | Patrin Pharma |
4/12/2018 | Zortress | Everolimus | Novartis | West-Ward Pharms |
4/13/2018 | Pravachol | Pravastatin Sodium | Bristol-Myers Squibb | Appco Pharma |
4/16/2018 | Adenocard | Adenosine | Astellas | Fresenius Kabi USA |
4/16/2018 | Claritin / Claritin Hives Relief | Loratadine (OTC) | Bayer | Aurobindo Pharma |
4/16/2018 | Invanz | Ertapenem Sodium | Merck Sharp & Dohme | ACS Dobfar Spa |
4/16/2018 | Children's Claritin | Loratadine (OTC) | Bayer | Sun Pharma Global |
4/16/2018 | Protopic | Tacrolimus | Leo Pharma | Glenmark Pharms |
4/17/2018 | Avapro | Irbesartan | Sanofi Aventis | Amneal |
4/17/2018 | Morphine Sulfate | Morphine Sulfate | West-Ward Pharms | ANI Pharms |
4/17/2018 | Parnate | Tranylcypromine Sulfate | Concordia Pharms | Kinedexe |
4/17/2018 | Actos | Pioglitazone HCl | Takeda | Prinston |
4/17/2018 | Zavesca | Miglustat | Actelion Pharms | Amerigen Pharms |
4/17/2018 | Cardura | Doxazosin Mesylate | Pfizer | Appco Pharma |
4/17/2018 | Children's Motrin | Ibuprofen (OTC) | Johnson and Johnson Consumer | Aurobindo |
4/17/2018 | Robaxin | Methocarbamol | West-Ward Pharms | Fresenius Kabi USA |
4/17/2018 | Clobex | Clobetasol Propionate | Galderma Labs | Apotex |
4/17/2018 | Xeloda | Capecitabine | Hoffmann La Roche | Eugia Pharma |
4/18/2018 | Xylocaine / Xylocaine Preservative Free | Lidocaine HCl | Fresenius Kabi USA | Spectra Medical Devices |
4/18/2018 | Spectazole | Econazole Nitrate | Alvogen Malta | Mylan |
4/19/2018 | Epivir | Lamivudine | ViiV Healthcare | Strides |
4/20/2018 | Xenazine | Tetrabenazine | Valeant | Lupin |
4/23/2018 | Medrol | Methylprednisolone | Pharmacia and Upjohn | Zydus |
4/23/2018 | Sensipar | Cinacalcet HCl | Amgen | Zydus |
4/23/2018 | Lidex | Fluocinonide | County Line Pharms | Glasshouse Pharms |
4/23/2018 | Lidex | Fluocinonide | County Line Pharms | MacLeods Pharms |
4/23/2018 | Sabril | Vigabatrin | Lundbeck Pharms | Teva |
4/24/2018 | Aciphex | Rabeprazole Sodium | Eisai | Alkem Labs |
4/26/2018 | Treanda | Bendamustine HCl | Cephalon | Mylan |
4/27/2018 | Sustiva | Efavirenz | Bristol-Myers Squibb | Hetero Labs |
4/27/2018 | Dilaudid | Hydromorphone HCl | Fresenius Kabi USA | Eurohealth Int'l |
4/27/2018 | Aromasin | Exemestane | Pharmacia and Upjohn | Cipla |
4/27/2018 | Vazculep | Phenylephrine HCl | Avadel Legacy | Cipla |
4/27/2018 | Phenylephrine HCl | Phenylephrine HCl | West-Ward Pharm | Cipla |
4/30/2018 | Bumex | Bumetanide | Validus Pharms | Zydus Pharms |
4/30/2018 | Celebrex | Celecoxib | GD Searle | Micro Labs |
4/30/2018 | Docetaxel | Docetaxel | Hospira | Mylan |
4/30/2018 | Sensipar | Cinacalcet HCl | Amgen | Strides Pharma |
4/30/2018 | Nexium | Esomeprazole Magnesium | AstraZeneca | Sun Pharm |
4/30/2018 | Kapvay | Clonidine HCl | Concordia Pharms | Mayne Pharma |
4/30/2018 | Oxycodone HCl | Oxycodone HCl | Genus LifeSciences / Vistapharm | Specgx |
5/1/2018 | Plaquenil | Hydroxychloroquine Sulfate | Concordia Pharms | Appco Pharma |
5/3/2018 | Ciloxan | Ciprofloxacin HCl | Novartis | Altaire Pharms |
5/4/2018 | Norvasc | Amlodipine Besylate | Pfizer | Sunshine Lake |
5/4/2018 | Bentyl / Bentyl Preservative Free | Dicyclomine HCl | Allergan | Akorn |
5/4/2018 | Protonix IV | Pantoprazole Sodium | Wyeth | Mylan |
5/4/2018 | Bloxiverz | Neostigmine Methylsulfate | Avadel Legacy | Luitpold Pharms |
5/4/2018 | Diovan | Valsartan | Novartis | Unichem Labs |
5/4/2018 | Anectine / Quelicin & Quelicin Preservative Free | Succinylcholine Chloride | Sandoz / Hospira | Zydus Pharms |
5/4/2018 | Vidaza | Azacitidine | Celgene | Cipla |
5/4/2018 | Keppra | Levetiracetam | UCB | Akorn |
5/4/2018 | Revatio | Sildenafil Citrate | Pfizer | Ajanta Pharma |
5/7/2018 | Coreg CR | Carvedilol Phosphate | SmithKline Beecham | Impax Labs |
5/7/2018 | Plavix | Clopidogrel Bisulfate | Sanofi Aventis | Prinston |
5/7/2018 | Nitrostat | Nitroglycerin | Pfizer | SigmaPharm Labs |
5/7/2018 | Robaxin / Robaxin-750 | Methocarbamol | Auxilium Pharms | Granules India |
5/7/2018 | Namenda | Memantine HCl | Allergan | CSPC Ouyi Pharm |
5/7/2018 | Cyclophosphamide | Cyclophosphamide | West-Ward Pharms | STI Pharma |
5/7/2018 | Lodosyn | Carbidopa | Aton | Zydus Pharms |
5/8/2018 | Plaquenil | Hydroxychloroquine Sulfate | Concordia Pharms | Alkaloida ZRT |
5/8/2018 | Edecrin | Ethacrynic Acid | Aton | Amneal |
5/8/2018 | Targretin | Bexarotene | Valeant | Amerigen Pharms |
5/9/2018 | Calcium Chloride 10% in Plastic Container | Calcium Chloride 10% in Plastic Container | Hospira | Int'l Medication Sys |
5/11/2018 | Zosyn | Piperacillin / Tazobactam | Wyeth | Fresenius Kabi |
5/11/2018 | Zosyn | Piperacillin / Tazobactam | Wyeth | Apollo Pharms |
5/11/2018 | Mephyton | Phytonadione | Valeant | Amneal |
5/14/2018 | Medrol | Methylprednisolone | Pharmacia and Upjohn | Tianjin Tianyao |
5/14/2018 | Neurontin | Gabapentin | Pfizer | ACI Healthcare |
5/14/2018 | Niaspan | Niacin | AbbVie | Jubilant Generics |
5/15/2018 | Arixtra | Fondaparinux Sodium | Mylan | Jiangsu Hengrui Med |
5/15/2018 | Nexium 24HR | Esomeprazole Magnesium (OTC) | AstraZeneca | Dr Reddys Labs |
5/15/2018 | Plaquenil | Hydroxychloroquine Sulfate | Concordia Pharms | Amneal |
5/16/2018 | Welchol | Colesevelam HCl | Daiichi Sankyo | Impax Labs |
5/17/2018 | Quillivant XR | Methylphenidate HCl | Nextwave Pharms | Actavis |
5/17/2018 | Actigall | Ursodiol | Allergan | Abhai |
5/18/2018 | Marinol | Dronabinol | AbbVie | Lannett |
5/18/2018 | Welchol | Colesevelam HCl | Daiichi Sankyo | Glenmark |
5/18/2018 | Zosyn | Piperacillin / Tazobactam | Wyeth | Fresenius Kabi |
5/18/2018 | Nexium | Esomeprazole Magnesium | AstraZeneca | HEC Pharm |
5/18/2018 | Triamcinolone Acetonide | Triamcinolone Acetonide | Mylan | MacLeods Pharms |
5/22/2018 | Cialis | Tadalafil | Eli Lilly | Teva |
5/23/2018 | Epiduo | Adapalene / Benzoyl Peroxide | Galderma Labs | Tolmar |
5/24/2018 | Jalyn | Dutasteride / Tamsulosin HCl | GlaxoSmithKline | Zydus Pharms |
5/24/2018 | Macrobid | Nitrofurantoin (Monohydrate/ Macrocrystals) | Alvogen Malta | Sunny Pharmatech |
5/25/2018 | Zegerid | Omeprazole / Sodium Bicarbonate | Santarus | Zydus Pharms |
5/25/2018 | Relpax | Eletriptan Hydrobromide | Pfizer | Ameal |
5/25/2018 | Benzaclin | Clindamycin Phosphate / Benzoyl Peroxide | Valeant | Taro |
5/30/2018 | Cardizem CD | Diltiazem HCl | Valeant | Par |
5/31/2018 | Tylenol | Acetaminophen (OTC) | Johnson and Johnson Consumer | Heritage Pharma |
5/31/2018 | Gelnique | Oxybutynin Chloride | Allergan | Par |
5/31/2018 | Vibramycin | Doxycycline Hyclate | Pfizer | Zydus Pharms |
5/31/2018 | Celebrex | Celecoxib | GD Searle | Amneal |
6/1/2018 | Angiomax | Bivalirudin | The Medicines Co | Mylan |
6/1/2018 | Corgard | Nadolol | US WorldMeds | RiconPharma |
6/4/2018 | Anectine / Quelicin & Quelicin Preservative Free | Succinylcholine Chloride | Sandoz / Hospira | Renaissance SSA |
6/4/2018 | Vanos | Fluocinonide | Medicis | Amneal |
6/5/2018 | Cubicin | Daptomycin | Cubist Pharms | Mylan |
6/5/2018 | Onexton | Clindamycin Phosphate / Benzoyl Peroxide | Dow Pharm | Taro |
6/5/2018 | Loestrin FE 1.5/30 | Ethinyl Estradiol / Norethindrone Acetate / Ferrous Fumarate | Apil | Glenmark |
6/5/2018 | Loestrin FE 1.5/30 | Ethinyl Estradiol / Norethindrone Acetate / Ferrous Fumarate | Apil | Glenmark |
6/6/2018 | Prilosec | Omeprazole Magnesium (OTC) | AstraZeneca | Aurobindo |
6/8/2018 | Zymaxid | Gatifloxacin | Allergan | Micro Labs |
6/8/2018 | Brevibloc | Esmolol HCl | Baxter Healthcare | Mylan |
6/8/2018 | Brevibloc | Esmolol HCl | Baxter Healthcare | Sagent Pharms |
6/8/2018 | Tamiflu | Oseltamivir Phosphate | Roche | Strides Pharma |
6/11/2018 | Viagra | Sildenafil Citrate | Pfizer | Torrent |
6/11/2018 | Viagra | Sildenafil Citrate | Pfizer | Hetero Labs |
6/11/2018 | Viagra | Sildenafil Citrate | Pfizer | Aurobindo |
6/11/2018 | Viagra | Sildenafil Citrate | Pfizer | Rubicon Research |
6/11/2018 | Naropin | Ropivacaine HCl | Fresenius Kabi USA | Inforlife |
6/12/2018 | Paxil CR | Paroxetine HCl | Apotex | Sciecure Pharma |
6/12/2018 | Isuprel | Isoproterenol HCl | Hospira | Cipla |
6/13/2018 | Vibramycin | Doxycycline Hyclate | Pfizer | Alembic Pharms |
6/14/2018 | Suboxone | Buprenorphine HCl / Naloxone HCl | Indivior | Dr Reddy's Labs |
6/14/2018 | Suboxone | Buprenorphine HCl / Naloxone HCl | Indivior | Dr Reddy's Labs |
6/14/2018 | Suboxone | Buprenorphine HCl / Naloxone HCl | Indivior | Mylan |
6/14/2018 | Wellbutrin XL | Bupropion HCl | Valeant | Yichang Humanwell |
6/15/2018 | Sustiva | Efavirenz | Bristol-Myers Squibb | Cipla |
6/15/2018 | Naropin | Ropivacaine HCl | Fresenius Kabi USA | Somerset Therapeutics |
6/15/2018 | Bloxiverz | Neostigmine Methylsulfate | Avadel Legacy | Amneal |
6/18/2018 | Starlix | Nateglinide | Novartis | Indicus Pharma |
6/18/2018 | Ancobon | Flucytosine | Valeant | Recipharm |
6/18/2018 | Lipitor | Atorvastatin Calcium | Pfizer | Graviti Pharms |
6/18/2018 | Isuprel | Isoproterenol HCl | Hospira | Amphastar Pharms |
6/19/2018 | Effient | Prasugrel | Eli Lilly | Amneal |
6/19/2018 | Fluocinonide | Fluocinonide | County Line Pharms | Teligent Pharma |
6/20/2018 | Exelon | Rivastigmine | Novartis | Mylan |
6/21/2018 | Sabril | Vigadrone | Lundbeck Pharms | Aucta Pharms |
6/21/2018 | Makena Preservative Free | Hydroxyprogesterone Caproate | Amag Pharma | Luitpold Pharms |
6/22/2018 | Estrostep FE | Norethindrone Acetate / Ethinyl Estradiol | Apil | Mylan |
6/22/2018 | Avodart | Dutasteride | GlaxoSmithKline | Pharmaceutics |
6/22/2018 | Cipro | Ciprofloxacin HCl | Bayer | Yiling Pharm |
6/22/2018 | Klor-Con | Potassium Chloride | Upsher-Smith | Yichang Humanwell |
6/25/2018 | Reyataz | Atazanavir Sulfate | Bristol-Myers Squibb | Aurobindo |
6/25/2018 | Invanz | Ertapenem Sodium | Merck Sharp & Dohme | Aurobindo |
6/26/2018 | Nicorette | Nicotine Polacrilex (OTC) | GlaxoSmithKline | Watson |
6/27/2018 | Depo-Medrol | Methylprednisolone Acetate | Pharmacia and Upjohn | Sagent Pharms |
6/27/2018 | Viagra | Sildenafil Citrate | Pfizer | Amneal |
6/28/2018 | Cancidas | Caspofungin Acetate | Merck | Sandoz |
6/29/2018 | Atelvia | Risedronate Sodium | Apil | Impax Labs |
6/29/2018 | Zometa | Zoledronic | Novartis | Gland Pharma |
6/29/2018 | Zometa | Zoledronic Acid | Novartis | Gland Pharma |
6/29/2018 | EMLA | Lidocaine / Prilocaine | Actavis | Teligent Pharma |
6/29/2018 | Seasonale | Icelevia | Teva | Aurobindo |
6/29/2018 | Motrin IB | Ibuprofen (OTC) | Johnson and Johnson Consumer | Strides Pharma |
6/29/2018 | Advil Liqui-Gels / Advil Migraine Liqui-Gels | Ibuprofen | Pfizer | Aurobindo |
6/29/2018 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Sciegen Pharms |
6/29/2018 | Maxzide-25 / Maxzide | Triamterene / Hydrochlorothiazide | Mylan | Zydus Pharms |
6/29/2018 | Claritin | Loratadine (OTC) | Bayer | Aurobindo |
6/29/2018 | Adalat CC | Nifedipine | Alvogen | Zydus Pharms |
GENERICally Speaking Summer 2018
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