Hydralazine Hydrochloride

ANDA 90527, held by Glenmark Pharms Ltd. Hydralazine Hydrochloride.

As of Nov 15, 2026, ANDA 90527 (Hydralazine Hydrochloride), held by Glenmark Pharms Ltd, was first approved by FDA on May 29, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: May 29, 2009
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
May 29, 2009	Original application	Approved	None posted

Products

4 strengths and forms


Hydralazine Hydrochloride10MG · tablet;oral	Hydralazine Hydrochloride	Rx
Hydralazine Hydrochloride25MG · tablet;oral	Hydralazine Hydrochloride	Rx
Hydralazine Hydrochloride50MG · tablet;oral	Hydralazine Hydrochloride	Rx
Hydralazine Hydrochloride100MG · tablet;oral	Hydralazine Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Oct 25, 2010	Supplement 1Labeling	Approved	None posted
May 29, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90527
Drugs@FDA: Overview at FDA
Company: Glenmark Pharmaceuticals

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