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Rectiv Approval History

  • FDA approved: Yes (First approved June 21st, 2011)
  • Brand name: Rectiv
  • Generic name: nitroglycerin
  • Dosage form: Ointment
  • Company: Allergan plc
  • Treatment for: Anal Fissure and Fistula

Rectiv (nitroglycerin) is a topical ointment for the treatment of moderate to severe pain associated with chronic anal fissures.

Development History and FDA Approval Process for Rectiv

Jun 22, 2011Approval ProStrakan Receives FDA Approval for Rectiv for the Treatment of Moderate to Severe Pain Associated With Chronic Anal Fissures
Jul 10, 2006FDA Issues Approvable Letter to Cellegy Pharmaceuticals for Cellegesic
Jan  9, 2006Cellegy Reports Review by Advisory Committee April 2006
Jun 30, 2005Cellegy Reports Status of Response Date for FDA Review
May  5, 2005Cellegy Reports New FDA Target Response Date of June 15
Apr 18, 2005Cellegy Responds to FDA Inquiries Concerning Cellegesic
Dec 23, 2004FDA Issues Not Approvable Letter for Cellegesic
Oct 14, 2004Cellegesic Granted Priority Review by FDA
Sep  1, 2004NDA for Cellegesic is Accepted for Review by FDA
Jun 30, 2004Cellegy Submits NDA for Cellegesic to Treat Chronic Anal Fissure Pain

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