FDA.reportPublic FDA data

Application 202912

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINEABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINETABLET;ORALEQ 300MG BASE;150MG;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-286ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINEABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINELUPIN LIMITEDANDACurrent
68180-286ABACAVIR, LAMIVUDINE AND ZIDOVUDINEABACAVIR , LAMIVUDINE AND ZIDOVUDINELupin Pharmaceuticals, Inc.ANDACurrent
68180-286ABACAVIR, LAMIVUDINE AND ZIDOVUDINEABACAVIR , LAMIVUDINE AND ZIDOVUDINELupin Pharmaceuticals, Inc.ANDACurrent
68180-286ABACAVIR, LAMIVUDINE AND ZIDOVUDINEABACAVIR , LAMIVUDINE AND ZIDOVUDINELupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32339ORIG2013-12-09