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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208990
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;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
11/15/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/23/2019 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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