ANDA 202938, held by Navinta LLC. Hydralazine Hydrochloride.
As of Nov 15, 2026, ANDA 202938 (Hydralazine Hydrochloride), held by Navinta LLC, was first approved by FDA on Mar 28, 2013, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydralazine Hydrochloride20MG/ML · injectable;injection | Hydralazine Hydrochloride | Rx |
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
