ANDA 84878, held by Hikma. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 84878 (Hydrochlorothiazide), held by Hikma, was first approved by FDA on Jan 31, 1977, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 1977 | Original application | Approved | None posted |
| Hydrochlorothiazide50MG · tablet;oral | Hydrochlorothiazide | Discontinued |
| Hydrochlorothiazide25MG · tablet;oral | Hydrochlorothiazide | Discontinued |
| Aug 20, 2020 | Supplement 50Labeling · Standard review | Approved | None posted |
| Aug 17, 2011 | Supplement 46Labeling | Approved | None posted |
| Jul 12, 2006 | Supplement 40Manufacturing | Approved | None posted |
| Jul 12, 2006 | Supplement 39Manufacturing | Approved | None posted |
| Mar 24, 2004 | Supplement 36Labeling | Approved | None posted |
| Nov 27, 1992 | Supplement 26Manufacturing | Approved | None posted |
| Jul 28, 1992 | Supplement 35Labeling | Approved | None posted |
| Mar 28, 1991 | Supplement 29Manufacturing | Approved | None posted |
| Feb 7, 1991 | Supplement 32Bioequivalence | Approved | None posted |
| Apr 25, 1989 | Supplement 51Labeling | Approved | None posted |
| Apr 25, 1989 | Supplement 25Labeling | Approved | None posted |
| Nov 29, 1988 | Supplement 24Labeling | Approved | None posted |
| Dec 20, 1985 | Supplement 20Manufacturing | Approved | None posted |
| Jul 20, 1983 | Supplement 19Manufacturing | Approved | None posted |
| Aug 9, 1982 | Supplement 14Manufacturing | Approved | None posted |
| Jan 31, 1977 | 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
