Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205302
Company: STRIDES ARCOLAB LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RILPIVIRINE RILPIVIRINE 25MG 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
09/29/2015 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205302Orig1s000TALtr_corrected.pdf

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