`
`ANDAApproval Reports> First-Time Generic Drug Approvals- March 2016
`
`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`First-Time Generic Drug Approvals- March 2016
`
`Generic
`Manufacturer/Applicant
`
`Brand Name
`
`Approval
`Date
`
`MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION USP, 1G/100
`ML
`
`OXICONAZOLE NITRATE CREAM, 1%
`
`HQ SPECIALTY
`PHARMA
`CORPORATION
`
`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%
`
`AM NEAL
`PHARMACEUTICALS
`
`VOLTAREN GEL, 1%
`
`3/18/2016
`
`091161
`
`MOMETASONE FUROATE NASAL SPRAY, 50 MCG
`
`APOTEX CORP
`
`NASON EX NASAL SPRAY
`
`3/22/2016
`
`6
`
`7
`
`204771
`
`BENDAMUSTINE HYDROCHLORIDE FOR INJECTION , 25 MGIVIAL,
`100 MGIVIAL (SINGLE DOSE VIAL)
`
`GLEN MARK
`PHARMACEUTICALS
`LIMITED
`
`TREANDA FOR
`INJECTION, 25MGIVIAL,
`100MGIVIAL
`
`8
`
`205476
`
`BENDAMUSTINE HYDROCHLORIDE FOR INJECTION , 25 MGIVIAL,
`100 MGIVIAL (SINGLE DOSE VIAL)
`
`INNOPHARMA
`LICENSING LLC
`
`TREANDA FOR
`INJECTION , 25MGIVIAL,
`100MGIVIAL
`
`3/24/2016
`
`3/24/2016
`
`9
`
`091039
`
`DAPTOMYCIN FOR INJECTION, 500 MGIVIAL
`
`10 205943
`
`LEVONORGESTREUETHINYL 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
`
`11
`
`202402
`
`IBUPROFEN LYSINE INJECTION, 20 MG/2 ML (10 MG/ML) SDV
`
`TEVA
`PHARMACEUTICALS
`USA
`
`CUBICIN FOR INJECTION
`
`3/24/2016
`
`LUPIN LIMITED
`
`QUARTETTE TABLETS
`
`3/29/2016
`
`EXELA PHARMA
`SCIENCES, LLC
`
`NEOPROFEN INJECTION
`
`3/30/2016
`
`ANDA (Generic) Drug Approvals -Previous Years
`I/Drugs/DevelopmentApprovaiProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovaiReports/ANDAGenericDrugApprovals/ucm050527.html
`
`http://www.fda.gov/Drugs/DevelopmentApprovaiProcess/H owDrugsareDevelopedandApproved/DrugandBiologicApproval Reports/AN DAGeneri cDrugApproval...
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`PTX0424
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`MEDA APTX0350307 4
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`PTX0424-0000 1
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`1
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`CIP2081
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`