Treats hypertension. NDA 17442, held by Pfizer. Prazosin Hydrochloride.
As of Nov 13, 2026, NDA 17442 (Minipress), held by Pfizer, was first approved by FDA on Jun 23, 1976, with 34 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 1976 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| MinipressEQ 5MG BASE · capsule;oral | Prazosin Hydrochloride | RxReference drug |
| MinipressEQ 1MG BASE · capsule;oral | Prazosin Hydrochloride | RxReference drug |
| MinipressEQ 2MG BASE · capsule;oral | Prazosin Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 8, 2016 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Feb 27, 2015 | Supplement 43Labeling · Standard review | Approved | |
| Jul 28, 2014 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Nov 4, 2013 | Supplement 41Labeling · Standard review | Approved | |
| Jul 10, 2009 | Supplement 35Labeling · Standard review | Approved | |
| Apr 6, 2009 | Supplement 33Labeling · Standard review | Approved | |
| Jun 12, 2001 | Supplement 29Labeling · Standard review | Approved | |
| May 10, 1994 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Aug 21, 1989 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| May 1, 1989 | Supplement 27Labeling | Approved | None posted |
| Oct 14, 1988 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Aug 29, 1988 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Jun 6, 1988 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Jul 14, 1987 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Apr 25, 1986 | Supplement 20Labeling | Approved | None posted |
| Apr 25, 1986 | Supplement 13Labeling | Approved | None posted |
| Sep 27, 1985 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Feb 26, 1985 | Supplement 19Labeling | Approved | None posted |
| Sep 13, 1984 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Aug 13, 1984 | Supplement 18Labeling | Approved | None posted |
| Aug 3, 1984 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Aug 1, 1984 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Nov 29, 1983 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Aug 6, 1982 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Feb 19, 1982 | Supplement 12Labeling | Approved | None posted |
| Feb 19, 1982 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Nov 17, 1981 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Sep 25, 1981 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Jul 30, 1981 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Jan 14, 1981 | Supplement 7Labeling | Approved | None posted |
| Jan 10, 1979 | Supplement 5Labeling | Approved | None posted |
| Nov 27, 1978 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Jul 13, 1977 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Jun 14, 1977 | Supplement 2Labeling | Approved | None posted |
| Jun 23, 1976 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
