ANDA 86242, held by Heritage. Hydralazine Hydrochloride.
As of Nov 15, 2026, ANDA 86242 (Hydralazine Hydrochloride), held by Heritage, was first approved by FDA on Oct 23, 1978, with 12 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 1978 | Original application | Approved | None posted |
| Hydralazine Hydrochloride10MG · tablet;oral | Hydralazine Hydrochloride | Discontinued |
| Hydralazine Hydrochloride50MG · tablet;oral | Hydralazine Hydrochloride | Discontinued |
| Hydralazine Hydrochloride25MG · tablet;oral | Hydralazine Hydrochloride | Discontinued |
| Hydralazine Hydrochloride100MG · tablet;oral | Hydralazine Hydrochloride | Discontinued |
| Apr 21, 2025 | Supplement 44Labeling · Standard review | Approved | None posted |
| Apr 21, 2025 | Supplement 51Labeling · Standard review | Approved | None posted |
| Feb 4, 2010 | Supplement 29Labeling | Approved | None posted |
| Mar 4, 1999 | Supplement 17Manufacturing | Approved | None posted |
| Dec 7, 1998 | Supplement 16Manufacturing | Approved | None posted |
| Jan 31, 1996 | Supplement 15Manufacturing | Approved | None posted |
| Sep 12, 1989 | Supplement 14Labeling | Approved | None posted |
| Oct 2, 1987 | Supplement 12Manufacturing | Approved | None posted |
| Jun 17, 1983 | Supplement 9Manufacturing | Approved | None posted |
| Sep 10, 1982 | Supplement 6Manufacturing | Approved | None posted |
| Jun 18, 1982 | Supplement 4Manufacturing | Approved | None posted |
| Jun 18, 1982 | Supplement 5Manufacturing | Approved | None posted |
| Oct 23, 1978 | 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
