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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204915
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABACAVIR AND LAMIVUDINE ABACAVIR;LAMIVUDINE 120MG;60MG TABLET; ORAL SUSPENSION None (Tentative Approval) 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
10/23/2014 ORIG-1 Tentative Approval Type 3 - New Dosage Form STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204915Orig1s000TAltr.pdf
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