Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202381
Company: MYLAN LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABACAVIR SULFATE; LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE 60MG; 30MG TABLET; ORAL 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
01/31/2012 ORIG-1 Tentative Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202381s000ltr.pdf

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