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ANDA Approvals
Fall 2017
| Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 7/5/2017 | Focalin XR | Dexmethylphenidate HCl | Novartis | Teva |
| 7/5/2017 | Focalin XR | Dexmethylphenidate HCl | Novartis | Impax Labs |
| 7/5/2017 | Azor | Amlodipine / Olmesartan Medoxomil | Daiichi Sankyo | Glenmark |
| 7/6/2017 | Topotecan HCl | Topotecan HCl | Hospira | Accord Healthcare |
| 7/6/2017 | Angiomax | Bivalirudin | The Medicines Co | Apotex |
| 7/6/2017 | Morphine Sulfate | Morphine Sulfate | West-Ward Pharms | Hi-Tech Pharmacal |
| 7/7/2017 | Ancobon | Flucytosine | Valeant | Novel Labs |
| 7/7/2017 | Travatan Z | Travoprost | Novartis | Mylan |
| 7/7/2017 | Busulfex | Busulfan | Otsuka | Sandoz |
| 7/7/2017 | Xenazine | Tetrabenazine | Valeant | Actavis |
| 7/7/2017 | Zyvox | Linezolid | Pharmacia and Upjohn | HQ Specialty Pharma |
| 7/7/2017 | Cardura | Doxazosin Mesylate | Pfizer | Zydus |
| 7/10/2017 | Namenda | Memantine HCl | Forest Labs | Zydus |
| 7/12/2017 | Androgel | Testosterone | AbbVie | Perrigo |
| 7/12/2017 | Effient | Prasugrel | Eli Lilly and Co | Mylan |
| 7/13/2017 | Inspra | Eplerenone | GD Searle | Accord Healthcare |
| 7/14/2017 | Concerta | Methylphenidate HCl | Janssen | Impax Labs |
| 7/17/2017 | Dermotic | Fluocinolone Acetonide | Hill Dermac | Perrigo |
| 7/17/2017 | Ethyol | Amifostine | Clinigen Healthcare | Mylan |
| 7/17/2017 | Cyklokapron | Tranexamic Acid | Pharmacia and Upjohn | Zydus |
| 7/17/2017 | Azor | Amlodipine / Olmesartan Medoxomil | Daiichi Sankyo | Alembic |
| 7/17/2017 | Renvela | Sevelamer Carbonate | Genzyme | Aurobindo |
| 7/18/2017 | Yaz | Drospirenone / Ethinyl Estradiol | Bayer | PII |
| 7/18/2017 | Robaxin | Methocarbamol | West-Ward Pharms | Sagent |
| 7/19/2017 | Indocin | Indomethacin Sodium | Recordati Rare | Navinta |
| 7/20/2017 | Erygel | Erythromycin | Mylan | Teligent Pharma |
| 7/21/2017 | Asacol HD | Mesalamine | Apil | Zydus |
| 7/21/2017 | Hyzaar | Losartan Potassium / Hydrochlorothiazide | Merck Sharp Dohme | Unichem Labs |
| 7/21/2017 | Cetirizine HCl Allergy (OTC) | Cetirizine HCl Allergy (OTC) | Bionpharma | Strides Pharma |
| 7/21/2017 | Lidex | Fluocinonide | Cnty Line Pharms | Novel Labs |
| 7/21/2017 | Sodium Chloride 0.9% | Sodium Chloride 0.9% | Hospira / Baxter Healthcare & Hospira | Spectra Mdcl Devices |
| 7/21/2017 | Vagifem | Estradiol | Novo Nordisk | Teva |
| 7/21/2017 | Edecrin | Ethacrynic Acid | Aton | Par Pharm |
| 7/21/2017 | Robaxin / Robaxin-750 | Methocarbamol | Auxilium Pharms | Beximco Pharms |
| 7/21/2017 | Oxycodone HCl | Oxycodone HCl | Lehigh Valley / Vistapharm | Abhai |
| 7/24/2017 | Desonide | Desonide | Perrigo | Glenmark |
| 7/25/2017 | Micardis | Telmisartan | Boehringer Ingelheim | Cadila Pharms |
| 7/26/2017 | Patanol | Olopatadine HCl | Novartis | Cipla |
| 7/26/2017 | Aromasin | Exemestane | Pharmacia and Upjohn | Upsher-Smith |
| 7/27/2017 | Rogaine (OTC) | Minoxidil (For Men) (OTC) | Johnson and Johnson | Watson |
| 7/27/2017 | Rogaine (OTC) | Minoxidil (For Women) (OTC) | Johnson and Johnson | Watson |
| 7/27/2017 | Calcium Chloride 10% | Calcium Chloride 10% | Hospira | Luitpold |
| 7/28/2017 | Delsym (OTC) | Dextromethorphan Polistirex (OTC) | Reckitt Benckiser | Amneal |
| 7/28/2017 | Concerta | Methylphenidate HCl | Janssen | Osmotica |
| 7/28/2017 | Viroptic | Trifluridine | Monarch Pharms | Hi-Tech Pharmacal |
| 7/28/2017 | Enablex | Darifenacin | Apil | MacLeods Pharms |
| 7/28/2017 | Corgard | Nadolol | US WorldMeds | Zydus |
| 7/28/2017 | Monodox | Doxycycline | Aqua Pharms | Alembic |
| 7/31/2017 | Zovirax | Acyclovir | Valeant | Glenmark |
| 7/31/2017 | Crestor | Rosuvastatin Calcium | IPR | Lupin |
| 7/31/2017 | Entocort EC | Budesonide | Perrigo | Amneal |
| 7/31/2017 | Zovirax | Acyclovir | Valeant Bermuda | Tolmar |
| 7/31/2017 | Sulfamylon | Mafenide Acetate | Mylan | RiconPharma |
| 7/31/2017 | Temodar | Temozolomide | Merck Sharp Dohme | Zydus |
| 7/31/2017 | Olux | Clobetasol Propionate | Mylan | Ingenus Pharms |
| 7/31/2017 | Viramune XR | Nevirapine | Boehringer Ingelheim | Sciegen Pharms |
| 7/31/2017 | Robaxin | Methocarbamol | West-Ward Pharms | Somerset Theraps |
| 7/31/2017 | Lidex | Fluocinonide | Cnty Line Pharms | Novel Labs |
| 8/2/2017 | Isuprel | Isoproterenol HCl | Hospira | Nexus Pharms |
| 8/3/2017 | Namenda XR | Memantine HCl | Forest Labs | Zydus |
| 8/3/2017 | Viramune | Nevirapine | Boehringer Ingelheim | Cipla |
| 8/4/2017 | Zanaflex | Tizanidine HCl | Acorda | Jubilant Generics |
| 8/7/2017 | Roxicodone | Oxycodone HCl | Mallinckrodt | Ascent Pharms |
| 8/7/2017 | Oxycodone HCl | Oxycodone HCl | Lehigh Valley | Hi-Tech Pharmacal |
| 8/8/2017 | Cardizem CD | Diltiazem HCl | Valeant | Zydus |
| 8/9/2017 | Taxotere | Docetaxel | Accord Healthcare / Sanofi Aventis | Jiangsu Hengrui Med |
| 8/10/2017 | Oxycodone HCl | Oxycodone HCl | Lehigh Valley / Vistapharm | Hi-Tech Pharmacal |
| 8/11/2017 | Fosrenol | Lanthanum Carbonate | Shire | Natco Pharma |
| 8/11/2017 | Relpax | Eletriptan Hydrobromide | Pfizer | Mylan |
| 8/11/2017 | Tiazac | Diltiazem HCl | Valeant | Zydus |
| 8/11/2017 | Flomax | Tamsulosin HCl | Boehringer Ingelheim | Alkem Labs |
| 8/11/2017 | Feldene | Piroxicam | Pfizer | Hikma Pharms |
| 8/11/2017 | Doxorubicin HCl | Doxorubicin HCl | Pharmacia and Upjohn | Gland Pharma |
| 8/14/2017 | Astelin | Azelastine HCl | Mylan | Zydus |
| 8/14/2017 | Azor | Amlodipine / Olmesartan Medoxomil | Daiichi Sankyo | Alkem Labs |
| 8/15/2017 | Micardis HCT | Telmisartan / Hydrochlorothiazide | Boehringer Ingelheim | Zydus |
| 8/15/2017 | Mestinon | Pyridostigmine Bromide | Valeant | Kinedexe |
| 8/15/2017 | Oxycodone HCl | Oxycodone HCl | Lehigh Valley | Pharm Assoc |
| 8/16/2017 | Zovirax | Acyclovir | Mylan | Carlsbad Technology |
| 8/16/2017 | Provigil | Modafinil | Cephalon | Appco Pharma |
| 8/18/2017 | Brisdelle | Paroxetine Mesylate | Sebela | Prinston |
| 8/18/2017 | Nexium 24Hr (OTC) | Esomeprazole Magnesium (OTC) | AstraZeneca | Perrigo |
| 8/18/2017 | Astelin | Azelastine HCl | Mylan | Alkem Labs |
| 8/21/2017 | Wellbutrin XL | Bupropion HCl | Valeant | Sinotherapeutics |
| 8/22/2017 | DDAVP | Desmopressin Acetate | Ferring | Sagent |
| 8/22/2017 | DDAVP | Desmopressin Acetate | Ferring | Sagent |
| 8/22/2017 | Geodon | Ziprasidone HCl | Pfizer | Zydus |
| 8/23/2017 | Atacand | Candesartan Cilexetil | AstraZeneca | Zydus |
| 8/23/2017 | Myfortic | Mycophenolic Acid | Novartis | Accord Healthcare |
| 8/23/2017 | Akovaz | Ephedrine Sulfate | Flamel Ireland | Sandoz |
| 8/25/2017 | Prograf | Tacrolimus | Astellas | Hospira |
| 8/25/2017 | Baraclude | Entecavir | Bristol Myers Squibb | Accord Healthcare |
| 8/25/2017 | Zetia | Ezetimibe | MSD | Aurobindo |
| 8/28/2017 | Astelin | Azelastine HCl | Mylan | Amneal |
| 8/29/2017 | Relpax | Eletriptan Hydrobromide | Pfizer | Ajanta |
| 8/29/2017 | Aggrenox | Aspirin / Dipyridamole | Boehringer Ingelheim | Zydus |
| 8/30/2017 | Oxycodone HCl | Oxycodone HCl | Lehigh Valley | ANI Pharms |
| 8/30/2017 | Prevacid | Lansoprazole | Takeda | Inventia Healthcare |
| 8/30/2017 | Nimbex | Cisatracurium Besylate | AbbVie | Jiangsu Hengrui Med |
| 8/31/2017 | Camptosar | Irinotecan HCl | Pfizer | Intas Pharms |
| 8/31/2017 | Aricept | Donepezil HCl | Eisai | Zydus |
| 8/31/2017 | Cellcept | Mycophenolate Mofetil HCl | Roche Palo | Zydus |
| 8/31/2017 | Comtan | Entacapone | Orion Pharma | Ajanta |
| 8/31/2017 | Skelaxin | Metaxalone | King Pharms | Sciegen Pharms |
| 8/31/2017 | Docetaxel | Docetaxel | Hospira | Ingenus Pharms |
| 9/1/2017 | Nexium | Esomeprazole Magnesium | AstraZeneca | Kremers Urban |
| 9/6/2017 | Haldol | Haloperidol | Janssen | Akorn |
| 9/6/2017 | Eloxatin | Oxaliplatin | Sanofi Aventis / Teva | Sanja Pharms |
| 9/6/2017 | Mucinex (OTC) | Guaifenesin (OTC) | Reckitt Benckiser | Guardian Pharms |
| 9/6/2017 | Oxycodone HCl | Oxycodone HCl | Lehigh Valley | Wes Pharma Inc |
| 9/7/2017 | Tricor | Fenofibrate | AbbVie | Sun Pharm |
| 9/7/2017 | Prometrium | Progesterone | Virtus Pharms | Amneal |
| 9/8/2017 | Rythmol SR | Propafenone HCl | GlaxoSmithKline | Glenmark |
| 9/8/2017 | Kenalog | Triamcinolone Acetonide | Ranbaxy | RiconPharma |
| 9/11/2017 | Intermezzo | Zolpidem Tartrate | Purdue Pharma | Par |
| 9/11/2017 | Urocit-K | Potassium Citrate | Mission Pharma | Strides Pharma |
| 9/11/2017 | Minastrin 24 FE | Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate | Apil | Amneal |
| 9/12/2017 | Minastrin 24 FE | Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate | Apil | Mylan |
| 9/12/2017 | Flagyl | Metronidazole | GD Searle | Lupin |
| 9/14/2017 | Tamiflu | Oseltamivir Phosphate | Roche | MacLeods Pharms |
| 9/14/2017 | Tamiflu | Oseltamivir Phosphate | Roche | Nesher Pharms |
| 9/14/2017 | Provigil | Modafinil | Cephalon | Zydus |
| 9/15/2017 | D.H.E. 45 | Dihydroergotamine Mesylate | Valeant | Hikma Pharms |
| 9/15/2017 | Desonide | Desonide | Perrigo | Glenmark |
| 9/18/2017 | Testim | Testosterone | Auxilium Pharms | Actavis |
| 9/18/2017 | Triamcinolone Acetonide | Triamcinolone Acetonide | Mylan | Teligent Pharma |
| 9/19/2017 | Lovaza | Omega-3-Acid Ethyl Esters | SmithKline Beecham | Strides Pharma |
| 9/19/2017 | Aricept | Donepezil HCl | Eisai | Cadila Pharms |
| 9/19/2017 | Sporanox | Itraconazole | Janssen | Zydus |
| 9/19/2017 | Nitrostat | Nitroglycerin | Pfizer | Glenmark |
| 9/19/2017 | Avalide | Irbesartan / Hydrochlorothiazide | Sanofi Aventis | Unichem Labs |
| 9/19/2017 | Sodium Chloride 0.9% | Sodium Chloride 0.9% | B Braun / Baxter Healthcare / Hospira / ICU Medical | Fresenius Kabi USA |
| 9/19/2017 | Precedex | Dexmedetomidine HCl | Hospira | Jiangsu Hengrui Med |
| 9/22/2017 | Dacogen | Decitabine | Otsuka Pharm | Chemi Spa |
| 9/22/2017 | Astepro | Azelastine HCl | Mylan Speciality | West-Ward Pharms |
| 9/22/2017 | Azor | Amlodipine / Olmesartan Medoxomil | Daiichi Sankyo | Zydus |
| 9/22/2017 | Avelox | Moxifloxacin HCl | Bayer | MSN Labs |
| 9/22/2017 | Clobex | Clobetasol Propionate | Galderma Labs | Lupin |
| 9/25/201 | Focalin | Dexmethylphenidate HCl | Novartis | Lannett |
| 9/25/2017 | Bloxiverz | Neostigmine Methylsulfate | Eclat Pharms | Amphastar Pharms |
| 9/27/2017 | Isopto Carpine | Pilocarpine HCl | Novartis | Akorn |
| 9/27/2017 | Acticlate | Doxycycline Hyclate | Aqua Pharms | Lupin |
| 9/28/2017 | Cyklokapron | Tranexamic Acid | Pharmacia and Upjohn | Akorn |
| 9/28/2017 | Pentam | Pentamidine Isethionate | Fresenius Kabi USA | Seton Pharms |
| 9/28/2017 | Prevacid | Lansoprazole | Takeda | Kremers Urban |
| 9/28/2017 | Keppra XR | Levetiracetam | UCB Inc | Pharmtak |
| 9/28/2017 | Exelon | Rivastigmine Tartrate | Novartis | Ajanta Pharma |
| 9/28/2017 | Entocort EC | Budesonide | Perrigo | Sciecure Pharma |
| 9/28/2017 | Renvela | Sevelamer Carbonate | Genzyme | Dr Reddys |
| 9/29/2017 | Cancidas | Caspofungin Acetate | Merck | Gland Pharma |
| 9/29/2017 | Prevacid 24 HR (OTC) | Lansoprazole (OTC) | GlaxoSmithKline | Kremers Urban |
| 9/29/2017 | Desferal | Deferoxamine Mesylate | Novartis | Gland Pharma |
| 9/29/2017 | Cancidas | Caspofungin Acetate | Merck | Mylan |
| 9/29/2017 | Monodox | Doxycycline | Aqua Pharms | Mayne Pharma |
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