Hydralazine Hydrochloride

ANDA 84106, held by Mutual Pharm. Hydralazine Hydrochloride.

As of Nov 15, 2026, ANDA 84106 (Hydralazine Hydrochloride), held by Mutual Pharm, was first approved by FDA on Aug 5, 1974, with 12 approved supplements and 0 published complete response letters.

First approved: Aug 5, 1974
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Aug 5, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydralazine Hydrochloride25MG · tablet;oral	Hydralazine Hydrochloride	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 73Manufacturing	Approved	None posted
Jan 30, 1995	Supplement 66Manufacturing	Approved	None posted
Jan 30, 1995	Supplement 65Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 72Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 71Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 70Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 68Manufacturing	Approved	None posted
Aug 11, 1988	Supplement 64Manufacturing	Approved	None posted
Mar 25, 1987	Supplement 61Manufacturing	Approved	None posted
Nov 18, 1985	Supplement 57Manufacturing	Approved	None posted
Nov 18, 1985	Supplement 56Manufacturing	Approved	None posted
Mar 2, 1984	Supplement 54Manufacturing	Approved	None posted
Aug 5, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 84106
Drugs@FDA: Overview at FDA
Company: Mutual Pharmaceutical Company

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