Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205217
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription AB No No
LAMIVUDINE LAMIVUDINE 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
12/18/2014 ORIG-1 Approval STANDARD

Label is not available on this site.

LAMIVUDINE

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPIVIR LAMIVUDINE 150MG TABLET;ORAL Prescription Yes AB 020564 VIIV HLTHCARE
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 091606 APOTEX
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 206974 APPCO PHARMA LLC
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 077464 AUROBINDO PHARMA LTD
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 202032 AUROBINDO PHARMA LTD
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 077221 CIPLA LTD
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 203586 ECI PHARMS LLC
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 203277 HETERO LABS LTD V
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 205217 LUPIN LTD
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 204528 MYLAN PHARMS INC

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPIVIR LAMIVUDINE 300MG TABLET;ORAL Prescription Yes AB 020564 VIIV HLTHCARE
LAMIVUDINE LAMIVUDINE 300MG TABLET;ORAL Prescription No AB 091606 APOTEX
LAMIVUDINE LAMIVUDINE 300MG TABLET;ORAL Prescription No AB 206974 APPCO PHARMA LLC
LAMIVUDINE LAMIVUDINE 300MG TABLET;ORAL Prescription No AB 077464 AUROBINDO PHARMA LTD
LAMIVUDINE LAMIVUDINE 300MG TABLET;ORAL Prescription No AB 202032 AUROBINDO PHARMA LTD
LAMIVUDINE LAMIVUDINE 300MG TABLET;ORAL Prescription No AB 077221 CIPLA LTD
LAMIVUDINE LAMIVUDINE 300MG TABLET;ORAL Prescription No AB 203277 HETERO LABS LTD V
LAMIVUDINE LAMIVUDINE 300MG TABLET;ORAL Prescription No AB 205217 LUPIN LTD
LAMIVUDINE LAMIVUDINE 300MG TABLET;ORAL Prescription No AB 204528 MYLAN PHARMS INC

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