Treats moderate to severe pain associated with chronic anal fissure. NDA 21359, held by Abbvie. Nitroglycerin.
As of Nov 14, 2026, NDA 21359 (Rectiv), held by Abbvie, was first approved by FDA on Jun 21, 2011, with 1 approved supplement and 0 published complete response letters.
RECTIV (nitroglycerin) Ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 2011 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rectiv0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · ointment;intra-anal | Nitroglycerin | DiscontinuedReference drug |
| Jul 23, 2024 | Supplement 5Labeling · Standard review | Approved | |
| Jun 21, 2011 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
