Minipress Xl

NDA 19775, held by Pfizer. Prazosin Hydrochloride.

As of Nov 13, 2026, NDA 19775 (Minipress Xl), held by Pfizer, was first approved by FDA on Jan 29, 1992, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 29, 1992
Review: Standard
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
Jan 29, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Minipress Xl2.5MG · tablet, extended release;oral	Prazosin Hydrochloride	Discontinued
Minipress Xl5MG · tablet, extended release;oral	Prazosin Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 19, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
May 10, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 29, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19775
Drugs@FDA: Overview at FDA
Company: Pfizer

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