Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077695
Company: AUROBINDO PHARMA LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMIVUDINE LAMIVUDINE 10MG/ML SOLUTION;ORAL Prescription AA 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
11/21/2016 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/77695TA_ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/29/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
08/29/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
08/29/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

LAMIVUDINE

SOLUTION;ORAL; 10MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPIVIR LAMIVUDINE 10MG/ML SOLUTION;ORAL Prescription Yes AA 020596 VIIV HLTHCARE
LAMIVUDINE LAMIVUDINE 10MG/ML SOLUTION;ORAL Prescription No AA 077695 AUROBINDO PHARMA LTD
LAMIVUDINE LAMIVUDINE 10MG/ML SOLUTION;ORAL Prescription No AA 203564 LANNETT CO INC

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