NDA 8857, held by Wyeth Ayerst. Promethazine Hydrochloride.
As of Nov 14, 2026, NDA 8857 (Phenergan), held by Wyeth Ayerst, was first approved by FDA on Aug 20, 1956, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 1956 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Phenergan25MG/ML · injectable;injection | Promethazine Hydrochloride | Discontinued |
| Phenergan50MG/ML · injectable;injection | Promethazine Hydrochloride | Discontinued |
| Sep 18, 1998 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 21, 1993 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Aug 16, 1993 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Feb 26, 1993 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jun 30, 1988 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| May 6, 1987 | Supplement 14Labeling · Standard review | Approved | None posted |
| Mar 31, 1987 | Supplement 12Labeling · Standard review | Approved | None posted |
| Mar 4, 1987 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| May 29, 1986 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1986 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1979 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1979 | Supplement 7Labeling · Standard review | Approved | None posted |
| Oct 30, 1978 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 20, 1956 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
