FDA.reportPublic FDA data

Application 203259

Type
ANDA
Sponsor
HETERO LABS LTD V

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
31722-739Lamivudine and ZidovudineLamivudine and ZidovudineCamber Pharmaceuticals, Inc.ANDACurrent
31722-739Lamivudine and ZidovudineLamivudine and ZidovudineCamber Pharmaceuticals, Inc.ANDACurrent
72865-144LAMIVUDINE AND ZIDOVUDINElamivudine and zidovudineXLCare Pharmaceuticals, IncANDACurrent
76282-115Lamivudine and ZidovudineLamivudine and ZidovudineExelan Pharmaceuticals Inc.ANDACurrent