ANDA 87602, held by Strides Pharma Intl. Hydroxyzine Hydrochloride.
As of Nov 15, 2026, ANDA 87602 (Hydroxyzine Hydrochloride), held by Strides Pharma Intl, was first approved by FDA on Jan 22, 1982, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 22, 1982 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydroxyzine Hydrochloride10MG · 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 30Labeling · Standard review | Approved | None posted |
| Feb 28, 2013 | Supplement 29Labeling · Standard review | Approved | None posted |
| Aug 3, 1989 | Supplement 27Labeling | Approved | None posted |
| Jun 20, 1989 | Supplement 26Labeling | Approved | None posted |
| Oct 15, 1987 | Supplement 22Manufacturing | Approved | None posted |
| Oct 15, 1987 | Supplement 23Manufacturing | Approved | None posted |
| Oct 15, 1987 | Supplement 24Manufacturing | Approved | None posted |
| Jun 9, 1987 | Supplement 16Manufacturing | Approved | None posted |
| Nov 8, 1983 | Supplement 9Manufacturing | Approved | None posted |
| Nov 8, 1983 | Supplement 10Manufacturing | Approved | None posted |
| Nov 8, 1983 | Supplement 12Manufacturing | Approved | None posted |
| Nov 8, 1983 | Supplement 13Manufacturing | Approved | None posted |
| Dec 10, 1982 | Supplement 8Manufacturing | Approved | None posted |
| Jan 22, 1982 | 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
