ANDA 89381, held by Sun Pharm Industries. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 89381 (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 Hydrochloride10MG · tablet;oral | Hydroxyzine Hydrochloride | Discontinued |
| Nov 8, 2016 | Supplement 35Labeling · Standard review | Approved | None posted |
| Mar 30, 2016 | Supplement 34Labeling · Standard review | Approved | None posted |
| Jun 3, 2014 | Supplement 30Labeling · Standard review | Approved | None posted |
| Jul 21, 2006 | Supplement 23Labeling | Approved | None posted |
| Apr 3, 2002 | Supplement 11Manufacturing | Approved | None posted |
| Mar 12, 2002 | Supplement 12Labeling | Approved | None posted |
| Mar 5, 2002 | Supplement 10Manufacturing | Approved | None posted |
| Feb 26, 2001 | Supplement 9Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 8Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 7Manufacturing | 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
