ANDA Approvals

Spring 2015

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
1/5/2015 Diovan valsartan Novartis IVAX Pharms.
1/5/2015 Diovan valsartan Novartis Watson Labs.
1/5/2015 Diovan valsartan Novartis Mylan
1/5/2015 Diovan valsartan Novartis Alembic Pharms.
1/5/2015 Diovan valsartan Novartis Lupin
1/5/2015 Diovan valsartan Novartis Aurobindo Pharma
1/5/2015 Diovan valsartan Novartis Torrent Pharms.
1/5/2015 Diovan valsartan Novartis Hetero Labs.
1/5/2015 Diovan valsartan Novartis Jubilant Generics
1/7/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Downstate Clinical NCM USA Bronx
1/8/2015 Levaquin levofloxacin Janssen Pharms. Hetero Labs.
1/12/2015 Risperdal risperidone Janssen Pharms. Silarx Pharms.
1/15/2015 Norvir ritonavir AbbVie Roxane
1/16/2015 Benzonatate benzonatate The Pharma Network Apotex
1/22/2015 Evista raloxifene hydrochloride Eli Lilly Watson Labs.
1/22/2015 Eliphos calcium acetate Cypress Pharm. Zydus Pharms.
1/26/2015 Nexium esomeprazole magnesium AstraZeneca Ivax Sub Teva Pharms.
1/27/2015 Vituz
hydrocodone bitartrate /
chlorpheniramine maleate
Cypress Pharm. Tris Pharma
1/28/2015 Vancocin Hydrochloride vancomycin hydrochloride Ani Pharms. Lupin
1/29/2015 Allegra-D
fexofenadine hydrochloride /
pseudoephedrine hydrochloride
Sanofi Aventis Sun Pharma Global
1/30/2015 Transderm Scop scopolamine Novartis Perrigo
1/30/2015 Namenda memantine hydrochloride Forest Labs. Mylan
1/30/2015 Lunesta eszopiclone Sunovion Pharms. MacLeods Pharms.
1/30/2015 Aricept donepezil hydrochloride Eisai Hetero Labs.
2/4/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Downstate Clinical Univ. North Dakota
2/4/2015 Ammonia N13 Ammonia N 13 Feinstein NCM USA Bronx
2/10/2015 Bromday bromfenac sodium Bausch and Lomb Inc. Paddock
2/11/2015 Celebrex celecoxib GD Searle Mylan
2/11/2015 Celebrex celecoxib GD Searle Watson Labs.
2/13/2015 Xyzal levocetirizine dihydrochloride UCB Apotex
2/18/2015 Larin 24 FE
norethindrone acetate /
ethinyl estradiol /
ferrous fumarate
Amneal Pharms. Novast Labs.
2/19/2015 Buprenorphine Hydrochloride buprenorphine hydrochloride Roxane Actavis Elizabeth
2/19/2015
Children's Cetirizine
Hydrochloride Allergy
(Over-the-Counter)
Children's Cetirizine
Hydrochloride Allergy
Sandoz Jubilant Generics
2/19/2015
Children's Cetirizine
Hydrochloride Allergy
(Over-the-Counter)
Children's Cetirizine
Hydrochloride Hives Relief
Sandoz Jubilant Generics
2/19/2015 Loestrin norethindrone acetate / ethinyl estradiol Warner Chilcott Famy Care
2/20/2015 Brevibloc esmolol hydrochloride Baxter Healthcare Luitpold
2/20/2015 Loestrin FE 1.5/30 norethindrone acetate / ethinyl estradiol Warner Chilcott Famy Care
2/20/2015 Lumigan bimatoprost Allergan Lupin
2/23/2015 Detrol tolterodine tartrate Pharmacia and Upjohn Ivax Sub Teva Pharms.
2/23/2015 Seasonique
levonorgestrel /
ethinyl estradiol and ethinyl estradiol
extended-cycle oral contraceptive tablets
Teva Glenmark Generics
2/23/2015 Avapro irbesartan Sanofi Aventis Jubilant Generics
2/24/2015 Glyset miglitol Pharmacia and Upjohn Orient Pharma
2/25/2015 Keppra XR levetiracetam UCB Inc Apotex
2/25/2015 Methylin methylphenidate hydrochloride Mallinckrodt Novel Labs.
2/27/2015 Skelaxin metaxalone King Pharms. Corepharma
3/4/2015 Antabuse disulfiram Odyssey Pharms. Mylan
3/6/2015 Vigamox moxifloxacin hydrochloride Alcon Pharms. Watson Labs.
3/9/2015 Fusilev levoleucovorin calcium Spectrum Pharms. Sandoz
3/12/2015 Singulair montelukast sodium Merck MacLeods Pharms.
3/13/2015 Enablex darifenacin hydrobromide Warner Chilcott Anchen Pharms.
3/16/2015 Celebrex celecoxib GD Searle Lupin
3/16/2015 Prozac fluoxetine hydrochloride Eli Lilly Sciegen Pharms.
3/18/2015 Viread tenofovir disoproxil fumarate Gilead Sciences Teva
3/19/2015 Zometa zoledronic acid Novartis Hospira
3/26/2015 Tasmar tolcapone Valeant Pharms. Par
3/30/2015 Exforge amlodipine besylate / valsartan Novartis Lupin
3/30/2015 Exforge amlodipine besylate / valsartan Novartis Matrix Labs.
3/30/2015 Exforge amlodipine besylate / valsartan Novartis Torrent Pharms.
3/30/2015 Exforge amlodipine besylate / valsartan Novartis Novel Labs.

Back to Top