Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090309
Company: MYLAN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE EQ 300MG BASE; 150MG; 300MG 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
07/15/2009 ORIG-1 Tentative Approval Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090309s000ltr.pdf

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