ANDA 85551, held by Baxter Hlthcare. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 85551 (Hydroxyzine Hydrochloride, Hydroxyzine), held by Baxter Hlthcare, was first approved by FDA on Aug 24, 1979, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 24, 1979 | Original application | Approved | None posted |
| Hydroxyzine Hydrochloride25MG/ML · injectable;injection | Hydroxyzine Hydrochloride | Discontinued |
| Hydroxyzine50MG/ML · injectable;injection | Hydroxyzine Hydrochloride | Discontinued |
| Jul 6, 2000 | Supplement 36Manufacturing | Approved | None posted |
| Jul 18, 1997 | Supplement 32Manufacturing | Approved | None posted |
| Jul 18, 1997 | Supplement 33Manufacturing | Approved | None posted |
| Aug 19, 1993 | Supplement 31Manufacturing | Approved | None posted |
| Aug 6, 1991 | Supplement 30Labeling | Approved | None posted |
| May 21, 1991 | Supplement 29Labeling | Approved | None posted |
| Apr 24, 1990 | Supplement 28Manufacturing | Approved | None posted |
| Oct 12, 1989 | Supplement 27Labeling | Approved | None posted |
| May 1, 1989 | Supplement 26Labeling | Approved | None posted |
| Dec 9, 1988 | Supplement 24Labeling | Approved | None posted |
| Oct 17, 1988 | Supplement 22Labeling | Approved | None posted |
| Oct 22, 1985 | Supplement 20Manufacturing | Approved | None posted |
| Mar 27, 1985 | Supplement 14Manufacturing | Approved | None posted |
| Jan 19, 1984 | Supplement 13Manufacturing | Approved | None posted |
| Sep 30, 1982 | Supplement 12Manufacturing | Approved | None posted |
| Aug 24, 1979 | Original application | 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
