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ANDA Approvals
Spring 2015
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. |
GENERICally Speaking Spring 2015
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