FDA.reportPublic FDA data

Application 079128

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMIVUDINE AND ZIDOVUDINELAMIVUDINE; ZIDOVUDINETABLET;ORAL150MG;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64380-707Lamivudine and ZidovudineLamivudine and ZidovudineStrides Pharma Science LimitedANDACurrent
64380-707Lamivudine and ZidovudineLamivudine and ZidovudineStrides Pharma Science LimitedANDACurrent
64380-707Lamivudine and ZidovudineLamivudine and ZidovudineStrides Shasun LimitedANDACurrent
64380-707Lamivudine and ZidovudineLamivudine and ZidovudineStrides Pharma Science LimitedANDACurrent
68071-3311Lamivudine and ZidovudineLamivudine and ZidovudineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6394Lamivudine and ZidovudineLamivudine and ZidovudinePreferred Pharmaceuticals Inc.ANDACurrent
68788-6394Lamivudine and ZidovudineLamivudine and ZidovudinePreferred Pharmaceuticals Inc.ANDACurrent
71335-0141Lamivudine and ZidovudineLamivudine and ZidovudineBryant Ranch PrepackANDACurrent
71335-0141Lamivudine and ZidovudineLamivudine and ZidovudineBryant Ranch PrepackANDACurrent