Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077672
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STAVUDINE STAVUDINE 30MG CAPSULE;ORAL Discontinued None No No
STAVUDINE STAVUDINE 40MG CAPSULE;ORAL Discontinued None No No
STAVUDINE STAVUDINE 15MG CAPSULE;ORAL Discontinued None No No
STAVUDINE STAVUDINE 20MG CAPSULE;ORAL Discontinued None 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
12/29/2008 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/10/2020 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/10/2020 SUPPL-9 Labeling

Label is not available on this site.

09/17/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/30/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

07/22/2011 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/29/2009 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

03/16/2009 SUPPL-2 Labeling

Label is not available on this site.

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