Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022547
Company: CIPLA LIMITED
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABACAVIR SULFATE ABACAVIR SULFATE 60MG 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
03/04/2011 ORIG-1 Tentative Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022547s000TAltr.pdf

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