ANDA 89383, held by Sun Pharm Industries. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 89383 (Hydroxyzine Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on May 19, 1986, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 19, 1986 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydroxyzine Hydrochloride50MG · tablet;oral | Hydroxyzine Hydrochloride | Discontinued |
| Nov 8, 2016 | Supplement 33Labeling · Standard review | Approved | None posted |
| Mar 30, 2016 | Supplement 32Labeling · Standard review | Approved | None posted |
| Jun 3, 2014 | Supplement 28Labeling · Standard review | Approved | None posted |
| Apr 3, 2002 | Supplement 12Manufacturing | Approved | None posted |
| Mar 12, 2002 | Supplement 13Labeling | Approved | None posted |
| Mar 5, 2002 | Supplement 10Manufacturing | Approved | None posted |
| Jun 19, 2001 | Supplement 11Manufacturing | Approved | None posted |
| Feb 26, 2001 | Supplement 9Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 7Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Dec 5, 1997 | Supplement 6Manufacturing | Approved | None posted |
| Feb 24, 1997 | Supplement 5Manufacturing | Approved | None posted |
| Jun 22, 1995 | Supplement 4Manufacturing | Approved | None posted |
| Jan 12, 1994 | Supplement 3Manufacturing | Approved | None posted |
| Oct 9, 1990 | Supplement 2Manufacturing | Approved | None posted |
| Dec 4, 1989 | Supplement 1Labeling | Approved | None posted |
| May 19, 1986 | 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
