Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202032
Company: AUROBINDO PHARMA 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
11/17/2011 ORIG-1 Approval Not Applicable Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202032Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2019 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

09/24/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/24/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

09/24/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/24/2019 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

09/24/2019 SUPPL-6 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

03/31/2012 SUPPL-1 Labeling-Package Insert

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 ARISE
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
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 090198 MACLEODS PHARMS LTD
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 078545 MYLAN LABS LTD
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 090457 STRIDES PHARMA

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 ARISE
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
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 090198 MACLEODS PHARMS LTD
LAMIVUDINE LAMIVUDINE 300MG TABLET;ORAL Prescription No AB 078545 MYLAN LABS LTD
LAMIVUDINE LAMIVUDINE 300MG TABLET;ORAL Prescription No AB 090457 STRIDES PHARMA

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