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ANDA Approvals
Spring 2018
Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
---|---|---|---|---|
1/8/2018 | Xenazine | Tetrabenazine | Valeant Pharms | Dr Reddys |
1/9/2018 | Tamiflu | Oseltamivir Phosphate | Roche | Lupin |
1/12/2018 | K-Tab | Potassium Chloride | AbbVie | Paddock |
1/16/2018 | Ultiva | Remifentanil HCl | Mylan | Fresenius Kabi |
1/17/2018 | Dilaudid | Hydromorphone HCl | Rhodes Pharms | Ascent Pharms |
1/19/2018 | Taxotere | Docetaxel | Accord Healthcare / Sanofi Aventis | Amneal |
1/19/2018 | Xyzal Allergy 24HR (OTC) | Levocetirizine Dihydrochloride (OTC) | Sanofi-Aventis | Dr Reddys |
1/23/2018 | Epiduo | Adapalene / Benzoyl Peroxide | Galderma Labs | Perrigo |
1/23/2018 | Bumex | Bumetanide | Validus Pharms | Upsher-Smith Labs |
1/23/2018 | Celebrex | Celecoxib | GD Searle | CSPC Ouyi Pharm |
1/24/2018 | Epiduo | Adapalene / Benzoyl Peroxide | Galderma Labs | Taro |
1/26/2018 | Viread | Tenofovir Disoproxil Fumarate | Gilead | Cipla |
1/26/2018 | Truvada | Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Aurobindo |
1/26/2018 | Viread | Tenofovir Disoproxil Fumarate | Gilead | Hetero Labs |
1/26/2018 | Viread | Tenofovir Disoproxil Fumarate | Gilead | Aurobindo |
1/26/2018 | Viread | Tenofovir Disoproxil Fumarate | Gilead | Strides |
1/26/2018 | Viread | Tenofovir Disoproxil Fumarate | Gilead | MacLeods |
1/26/2018 | Argatroban | Argatroban | Novartis | Amneal |
1/26/2018 | Feldene | Piroxicam | Pfizer | Strides |
1/29/2018 | Kapvay | Clonidine HCl | Concordia Pharms | Jubilant Generics |
2/1/2018 | Concerta | Methylphenidate HCl | Janssen | Amneal |
2/1/2018 | Niaspan | Niacin | AbbVie | Aurobindo |
2/2/2018 | Effient | Prasugrel | Eli Lilly | Accord Healthcare |
2/2/2018 | Opana | Oxymorphone HCl | Endo | Ascent Pharms |
2/6/2018 | Toprol-XL | Metoprolol Succinate | Aralez Pharms | Novast Labs |
2/7/2018 | Syprine | Trientine HCl | Aton | Watson |
2/8/2018 | Cleocin T | Clindamycin Phosphate | Pharmacia and Upjohn | Glasshouse Pharms |
2/9/2018 | Tricor | Fenofibrate | AbbVie | Amneal |
2/9/2018 | Namenda | Memantine HCl | Allergan | Apotex |
2/12/2018 | Copaxone | Glatopa | Teva | Sandoz |
2/13/2018 | Cardura | Doxazosin Mesylate | Pfizer | Heritage Pharma |
2/13/2018 | Diprolene | Betamethasone Dipropionate | Merck Sharp Dohme | Teligent Pharma |
2/15/2018 | Treximet | Sumatriptan / Naproxen Sodium | Pernix Ireland | Aurobindo |
2/16/2018 | Adenocard | Adenosine | Astellas | Gland Pharma |
2/20/2018 | Tamiflu | Oseltamivir Phosphate | Roche | Lupin |
2/21/2018 | Feldene | Piroxicam | Pfizer | Laboratorios Cinfa |
2/22/2018 | Zantac 150 (OTC) | Ranitidine HCl (OTC) | Sanofi | Vivimed Global |
2/23/2018 | Strattera | Atomoxetine HCl | Eli Lilly | Dr Reddys |
2/23/2018 | Lotronex | Alosetron HCl | Sebela Ireland | Par |
2/23/2018 | Tamiflu | Oseltamivir Phosphate | Roche | Hetero Labs |
2/26/2018 | Ritalin LA | Methylphenidate HCl | Novartis | Mayne Pharma |
2/26/2018 | Suprane | Desflurane | Baxter Healthcare | Shanghai Hengrui |
2/26/2018 | Viread | Tenofovir Disoproxil Fumarate | Gilead | Laurus Labs |
2/27/2018 | Precedex | Dexmedetomidine HCl | Hospira | Zydus |
2/27/2018 | Yaz | Lo-Zumandimine | Bayer | Aurobindo |
2/28/2018 | Activella | Estradiol / Norethindrone Acetate | Amneal | Accord Healthcare |
3/2/2018 | Bystolic | Nebivolol HCl | Allergan | Torrent |
3/2/2018 | Viread | Tenofovir Disoproxil Fumarate | Gilead | Qilu Tianhe |
3/2/2018 | Ritalin | Methylphenidate HCl | Novartis | Bionpharma |
3/5/2018 | Eloxatin | Oxaliplatin | Sanofi Aventis / Teva | Actavis |
3/5/2018 | Zantac 75 (OTC) | Ranitidine HCl (OTC) | Sanofi | Vivimed Global |
3/5/2018 | Urocit-K | Potassium Citrate | Mission Pharma | Teva |
3/6/2018 | Nuvigil | Armodafinil | Cephalon | Aurobindo |
3/6/2018 | Gablofen | Baclofen | Piramal | Mylan |
3/7/2018 | Integrilin | Eptifibatide | Schering | Sagent |
3/7/2018 | Zovirax | Acyclovir | Mylan | Yiling Pharm |
3/8/2018 | Sensipar | Cinacalcet HCl | Amgen | Aurobindo |
3/8/2018 | Sensipar | Cinacalcet HCl | Amgen | Cipla |
3/9/2018 | Zanaflex | Tizanidine HCl | Covis Pharma | Zydus |
3/12/2018 | Sustiva | Efavirenz | Bristol-Myers Squibb | Strides |
3/13/2018 | Sabril | Vigabatrin | Lundbeck | Amneal |
3/14/2018 | Ziagen | Abacavir Sulfate | ViiV Healthcare | Aurobindo |
3/16/2018 | Zegerid (OTC) | Omeprazole / Sodium Bicarbonate (OTC) | Bayer | Zydus |
3/16/2018 | Solodyn | Minocycline HCl | Medicis | Alkem Labs |
3/16/2018 | Naropin | Ropivacaine HCl | Fresenius Kabi | Akorn |
3/16/2018 | Dacogen | Decitabine | Otsuka | Sagent |
3/16/2018 | Topicort | Desoximetasone | Taro | Lupin |
3/16/2018 | Glucophage XR | Metformin HCl | Bristol-Myers Squibb | Granules |
3/19/2018 | Cyclophosphamide | Cyclophosphamide | West-Ward Pharms | Amerigen Pharms |
3/19/2018 | Glucophage XR | Metformin HCl | Bristol-Myers Squibb | Alignscience Pharma |
3/20/2018 | Renvela | Sevelamer Carbonate | Genzyme | Sandoz |
3/20/2018 | Keppra | Levetiracetam | UCB | Hainan Poly Pharm |
3/20/2018 | Ultravate | Halobetasol Propionate | Sun Pharm Inds | Teligent Pharma |
3/21/2018 | Concerta | Methylphenidate HCl | Janssen | Actavis |
3/21/2018 | Patanol | Olopatadine HCl | Novartis | Micro Labs |
3/21/2018 | Loestrin 24 FE | Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate | Apil | Apotex |
3/21/2018 | Lioresal | Baclofen | Saol Theraps Res | Mylan |
3/22/2018 | Concerta | Methylphenidate HCl | Janssen | Actavis |
3/23/2018 | Aloxi | Palonosetron HCl | Helsinn Healthcare | Teva |
3/23/2018 | Lialda | Mesalamine | Shire | Actavis |
3/23/2018 | Toprol-XL | Metoprolol Succinate | Aralez Pharms | Zydus |
3/26/2018 | Tikosyn | Dofetilide | Pfizer | Sigmapharm Labs |
3/26/2018 | Clobex | Clobetasol Propionate | Galderma Labs | Lupin |
3/26/2018 | Clobex | Clobetasol Propionate | Galderma Labs | Taro |
3/26/2018 | Clobex | Clobetasol Propionate | Galderma Labs | Glenmark |
3/26/2018 | Yasmin | Zumandimine | Bayer | Aurobindo |
3/28/2018 | Advil Liqui-Gels (OTC) / Advil Migraine Liqui-Gels (OTC) | Ibuprofen (OTC) | Pfizer | Strides |
3/30/2018 | Nimbex | Cisatracurium Besylate | AbbVie | Hospira |
3/30/2018 | Nimbex | Cisatracurium Besylate | AbbVie | Hospira |
3/30/2018 | Lipitor | Atorvastatin Calcium | Pfizer | Accord Healthcare |
3/30/2018 | Dolophine | Methadone HCl | West-Ward Pharms | Sun Pharm |
GENERICally Speaking Spring 2018
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