Drugs

First-Time Generic Drug Approvals - March 2016

 ANDA NumberGeneric Drug NameGeneric Manufacturer/ApplicantBrand NameApproval Date

1

207349

MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION USP, 1G/100 ML     

HQ SPECIALTY PHARMA CORPORATION

MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION

3/2/2016

2

205076

OXICONAZOLE NITRATE CREAM, 1%       

TARO PHARMACEUTICALS USA, INC.

OXISTAT CREAM

3/7/2016 

3

077342

SILDENAFIL CITRATE TABLETS, 25 MG (BASE), 50 MG (BASE), 100 MG (BASE)

TEVA PHARMACEUTICALS USA, INC.

VIAGRA (SILDENAFIL CITRATE) TABLETS, 25 MG, 50 MG, 100 MG

3/9/2016

4

206485

MAGNESIUM SULFATE IN WATER FOR INJECTION, 40 MG/ML, 80 MG/ML  

FRESENIUS KABI USA, LLC

MAGNESIUM SULFATE IN WATER FOR INJECTION

3/15/2016

5

208077

DICLOFENAC SODIUM TOPICAL GEL, 1%     

AMNEAL PHARMACEUTICALS

VOLTAREN GEL, 1%

3/18/2016

6

091161

MOMETASONE FUROATE NASAL SPRAY, 50 MCG     

APOTEX CORP

NASONEX NASAL SPRAY

3/22/2016

7

204771

BENDAMUSTINE HYDROCHLORIDE FOR INJECTION, 25 MG/VIAL, 100 MG/VIAL (SINGLE DOSE VIAL)

GLENMARK PHARMACEUTICALS LIMITED

TREANDA FOR INJECTION, 25MG/VIAL, 100MG/VIAL

3/24/2016

8

205476

BENDAMUSTINE HYDROCHLORIDE FOR INJECTION, 25 MG/VIAL, 100 MG/VIAL (SINGLE DOSE VIAL)

INNOPHARMA LICENSING LLC

TREANDA FOR INJECTION, 25MG/VIAL, 100MG/VIAL

3/24/2016

9

091039

DAPTOMYCIN FOR INJECTION, 500 MG/VIAL

TEVA PHARMACEUTICALS USA

CUBICIN FOR INJECTION

3/24/2016

10

205943

LEVONORGESTREL/ETHINYL ESTRADIOL TABS USP/ETHINYL ESTRADIOL 0.15 MG/0.02 MG/0.01 MG 0.15 MG/0.025 MG/0.01 MG 0.15 MG/0.03 MG/0.01 MG   

LUPIN LIMITED

QUARTETTE TABLETS

3/29/2016

11

202402

IBUPROFEN LYSINE INJECTION, 20 MG/2 ML (10 MG/ML) SDV 

EXELA PHARMA SCIENCES, LLC

NEOPROFEN INJECTION

3/30/2016

 

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