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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090457
Company: STRIDES PHARMA
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
04/19/2018 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090457s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/26/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/26/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/14/2016 SUPPL-8 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 077464 AUROBINDO PHARMA
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 203586 BRECKENRIDGE
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 077221 CIPLA
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
LAMIVUDINE LAMIVUDINE 150MG TABLET;ORAL Prescription No AB 206974 UPSHER SMITH LABS

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 077464 AUROBINDO PHARMA
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
LAMIVUDINE LAMIVUDINE 300MG TABLET;ORAL Prescription No AB 206974 UPSHER SMITH LABS
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