Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079124
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/17/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/079124s000ltr.pdf

LAMIVUDINE AND ZIDOVUDINE

TABLET;ORAL; 150MG;300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COMBIVIR LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET;ORAL Prescription Yes AB 020857 VIIV HLTHCARE
LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET;ORAL Prescription No AB 077558 AUROBINDO PHARMA LTD
LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET;ORAL Prescription No AB 202418 AUROBINDO PHARMA LTD
LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET;ORAL Prescription No AB 079124 HETERO LABS LTD III
LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET;ORAL Prescription No AB 203259 HETERO LABS LTD V
LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET;ORAL Prescription No AB 090246 LUPIN LTD
LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET;ORAL Prescription No AB 204005 MYLAN PHARMS INC
LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET;ORAL Prescription No AB 079128 STRIDES PHARMA
LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET;ORAL Prescription No AB 079081 TEVA PHARMS

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