ANDA 203110, held by Pharmobedient. Hydralazine Hydrochloride.
As of Nov 15, 2026, ANDA 203110 (Hydralazine Hydrochloride), held by Pharmobedient, was first approved by FDA on Jun 29, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 29, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydralazine Hydrochloride20MG/ML ยท injectable;injection | 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
