NDA 20755, held by Pfizer. Alprostadil.
As of Nov 13, 2026, NDA 20755 (Caverject), held by Pfizer, was first approved by FDA on Oct 31, 1997, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 1997 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Caverject0.005MG/ML · injectable;injection | Alprostadil | Discontinued |
| Caverject0.01MG/ML · injectable;injection | Alprostadil | Discontinued |
| Caverject0.02MG/ML · injectable;injection | Alprostadil | Discontinued |
| Sep 2, 2003 | Supplement 5Labeling · Standard review | Approved | |
| Dec 20, 2001 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 31, 1997 | Original applicationNew formulation or manufacturer · Standard 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
