FDA.reportPublic FDA data

Application 203277

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMIVUDINELAMIVUDINETABLET;ORAL150MGNoNo
002LAMIVUDINELAMIVUDINETABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-753LamivudineLamivudineCamber Pharmaceuticals, Inc.ANDACurrent
31722-753LamivudineLamivudineCamber Pharmaceuticals, Inc.ANDACurrent
31722-754LamivudineLamivudineCamber Pharmaceuticals, Inc.ANDACurrent
31722-754LamivudineLamivudineCamber Pharmaceuticals, Inc.ANDACurrent
50268-459LamivudineLamivudineAvPAKANDACurrent
50268-459LamivudineLamivudineAvPAKANDACurrent
50268-459LamivudineLamivudineAvPAKANDACurrent
50268-460LamivudineLamivudineAvPAKANDACurrent
50268-460LamivudineLamivudineAvPAKANDACurrent
50268-460LamivudineLamivudineAvPAKANDACurrent
70518-0440LamivudineLamivudineREMEDYREPACK INC.ANDACurrent
70518-1634LamivudineLamivudineREMEDYREPACK INC.ANDACurrent
70518-1634LamivudineLamivudineREMEDYREPACK INC.ANDACurrent