Rectiv FDA Approval History
FDA Approved: Yes (First approved June 21, 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 timeline for Rectiv
Date | Article |
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Jun 22, 2011 | Approval ProStrakan Receives FDA Approval for Rectiv for the Treatment of Moderate to Severe Pain Associated With Chronic Anal Fissures |
Jul 10, 2006 | FDA Issues Approvable Letter to Cellegy Pharmaceuticals for Cellegesic |
Jan 9, 2006 | Cellegy Reports Review by Advisory Committee April 2006 |
Jun 30, 2005 | Cellegy Reports Status of Response Date for FDA Review |
May 5, 2005 | Cellegy Reports New FDA Target Response Date of June 15 |
Apr 18, 2005 | Cellegy Responds to FDA Inquiries Concerning Cellegesic |
Dec 23, 2004 | FDA Issues Not Approvable Letter for Cellegesic |
Oct 14, 2004 | Cellegesic Granted Priority Review by FDA |
Sep 1, 2004 | NDA for Cellegesic is Accepted for Review by FDA |
Jun 30, 2004 | Cellegy Submits NDA for Cellegesic to Treat Chronic Anal Fissure Pain |
Further information
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