ANDA 90413, held by Pharmobedient. Hydralazine Hydrochloride.
As of Nov 15, 2026, ANDA 90413 (Hydralazine Hydrochloride), held by Pharmobedient, was first approved by FDA on Dec 8, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 8, 2010 | 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
