ANDA 83965, held by Chartwell Rx. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 83965 (Hydrochlorothiazide), held by Chartwell Rx, was first approved by FDA on Mar 21, 1977, with 18 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 21, 1977 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrochlorothiazide50MG · tablet;oral | Hydrochlorothiazide | Discontinued |
| Aug 20, 2020 | Supplement 97Labeling · Standard review | Approved | None posted |
| Oct 6, 2000 | Supplement 96Manufacturing | Approved | None posted |
| Mar 13, 1996 | Supplement 93Labeling | Approved | None posted |
| Aug 2, 1995 | Supplement 92Labeling | Approved | None posted |
| Mar 13, 1995 | Supplement 91Labeling | Approved | None posted |
| Jul 15, 1993 | Supplement 89Labeling | Approved | None posted |
| Nov 13, 1991 | Supplement 87Labeling | Approved | None posted |
| Jul 25, 1991 | Supplement 86Labeling | Approved | None posted |
| Aug 3, 1990 | Supplement 85Labeling | Approved | None posted |
| Aug 3, 1990 | Supplement 84Labeling | Approved | None posted |
| Aug 3, 1990 | Supplement 83Labeling | Approved | None posted |
| Feb 12, 1990 | Supplement 82Labeling | Approved | None posted |
| Jan 18, 1989 | Supplement 80Manufacturing | Approved | None posted |
| Sep 1, 1988 | Supplement 78Manufacturing | Approved | None posted |
| Apr 4, 1988 | Supplement 81Labeling | Approved | None posted |
| Aug 9, 1983 | Supplement 71Manufacturing | Approved | None posted |
| Mar 21, 1983 | Supplement 70Manufacturing | Approved | None posted |
| May 19, 1982 | Supplement 69Manufacturing | Approved | None posted |
| Mar 21, 1977 | Original application | Approved |
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
