Prazosin Hydrochloride

ANDA 72577, held by Ani Pharms. Prazosin Hydrochloride.

As of Nov 15, 2026, ANDA 72577 (Prazosin Hydrochloride), held by Ani Pharms, was first approved by FDA on Apr 10, 1989, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 10, 1989
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
Apr 10, 1989	Original application	Approved	None posted

Products

3 strengths and forms


Prazosin HydrochlorideEQ 2MG BASE · capsule;oral	Prazosin Hydrochloride	Discontinued
Prazosin HydrochlorideEQ 1MG BASE · capsule;oral	Prazosin Hydrochloride	Discontinued
Prazosin HydrochlorideEQ 5MG BASE · capsule;oral	Prazosin Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jan 24, 1994	Supplement 6Manufacturing	Approved	None posted
Jun 4, 1990	Supplement 4Labeling	Approved	None posted
Apr 10, 1989	Original application	Approved	None posted

Identifiers

Application: ANDA 72577
Drugs@FDA: Overview at FDA
Company: ANI 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