Hydralazine Hydrochloride

ANDA 87751, held by Usl Pharma. Hydralazine Hydrochloride.

As of Nov 15, 2026, ANDA 87751 (Hydralazine Hydrochloride), held by Usl Pharma, was first approved by FDA on Mar 29, 1982, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 29, 1982
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Mar 29, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydralazine Hydrochloride50MG · tablet;oral	Hydralazine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Mar 5, 1985	Supplement 2Manufacturing	Approved	None posted
Mar 29, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87751
Drugs@FDA: Overview at FDA
Company: USL Pharma

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