Midodrine Hydrochloride

ANDA 76449, held by Impax Pharms. Midodrine Hydrochloride.

As of Nov 15, 2026, ANDA 76449 (Midodrine Hydrochloride), held by Impax Pharms, was first approved by FDA on May 27, 2004, with 2 approved supplements and 0 published complete response letters.

First approved: May 27, 2004
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 27, 2004	Original application	Approved	None posted

Products

3 strengths and forms


Midodrine Hydrochloride2.5MG · tablet;oral	Midodrine Hydrochloride	Discontinued
Midodrine Hydrochloride5MG · tablet;oral	Midodrine Hydrochloride	Discontinued
Midodrine Hydrochloride10MG · tablet;oral	Midodrine Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Nov 13, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Dec 16, 2005	Supplement 1Labeling	Approved	None posted
May 27, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76449
Drugs@FDA: Overview at FDA
Company: Impax Pharms

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