ANDA 91679, held by Actavis Grp Ptc. Hydralazine Hydrochloride.
As of Nov 15, 2026, ANDA 91679 (Hydralazine Hydrochloride), held by Actavis Grp Ptc, was first approved by FDA on Mar 4, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 2013 | Original application | Approved | None posted |
| Hydralazine Hydrochloride10MG · tablet;oral | Hydralazine Hydrochloride | Discontinued |
| Hydralazine Hydrochloride25MG · tablet;oral | Hydralazine Hydrochloride | Discontinued |
| Hydralazine Hydrochloride50MG · tablet;oral | Hydralazine Hydrochloride | Discontinued |
| Hydralazine Hydrochloride100MG · tablet;oral | Hydralazine Hydrochloride | Discontinued |
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
