FDA.reportPublic FDA data

Application 079124

Type
ANDA
Sponsor
HETERO LABS LTD III

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
31722-506LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINECamber Pharmaceuticals, Inc.ANDACurrent
31722-506LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINECamber Pharmaceuticals, Inc.ANDACurrent
31722-506LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINECamber Pharmaceuticals, Inc.ANDACurrent
31722-506LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINECamber Pharmaceuticals, Inc.ANDACurrent
43063-900lamiVUDine and ZIDOVUDINElamiVUDine and ZIDOVUDINEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-900lamiVUDine and ZIDOVUDINElamiVUDine and ZIDOVUDINEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-900LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-900LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-900LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-900LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-900LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3920LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEA-S Medication SolutionsANDACurrent
50268-456LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEAvPAKANDACurrent
50268-456LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEAvPAKANDACurrent
50268-456LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEAvPAKANDACurrent
68071-4450LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4450LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4450LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4450LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINENuCare Pharmaceuticals,Inc.ANDACurrent
68788-7298LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7298LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7298LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEPreferred Pharmaceuticals Inc.ANDACurrent
71335-0639LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEBryant Ranch PrepackANDACurrent
71335-0639LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEBryant Ranch PrepackANDACurrent
71335-0639LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINEBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31414ORIG2008-04-28