Treats hypertension. ANDA 71344, held by Watson Labs. Minoxidil.
As of Nov 15, 2026, ANDA 71344 (Minoxidil), held by Watson Labs, was first approved by FDA on Mar 3, 1987, with 16 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relationship in such patients has not been defined. Minoxidil reduced supine diastolic blood pressure by 20 mm Hg or to 90 mm Hg or less in approximately 75% of patients, most of who had hypertension that could not be controlled by other drugs.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 3, 1987 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Minoxidil2.5MG · tablet;oral | Minoxidil | Rx |
| Aug 9, 2024 | Supplement 41Labeling · Standard review | Approved | None posted |
| May 19, 2020 | Supplement 37Labeling · Standard review | Approved | None posted |
| Mar 24, 2003 | Supplement 17Labeling | Approved | None posted |
| Jun 8, 2001 | Supplement 15Manufacturing | Approved | None posted |
| Apr 25, 2001 | Supplement 16Manufacturing | Approved | None posted |
| Jul 31, 2000 | Supplement 14Manufacturing | Approved | None posted |
| Apr 1, 1998 | Supplement 12Manufacturing | Approved | None posted |
| Apr 17, 1996 | Supplement 11Labeling | Approved | None posted |
| May 13, 1993 | Supplement 10Labeling | Approved | None posted |
| Jan 28, 1991 | Supplement 9Manufacturing | Approved | None posted |
| Sep 7, 1988 | Supplement 6Manufacturing | Approved | None posted |
| Sep 7, 1988 | Supplement 5Labeling | Approved | None posted |
| Jul 1, 1988 | Supplement 4Labeling | Approved | None posted |
| Mar 1, 1988 | Supplement 3Labeling | Approved | None posted |
| Aug 12, 1987 | Supplement 2Manufacturing | Approved | None posted |
| Aug 12, 1987 | Supplement 1Manufacturing | Approved | None posted |
| Mar 3, 1987 | Original application | 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
