Treats hypertension. ANDA 72709, held by Sun Pharm Industries. Minoxidil.
As of Nov 15, 2026, ANDA 72709 (Minoxidil), held by Sun Pharm Industries, was first approved by FDA on Dec 13, 1995, with 8 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 |
|---|---|---|---|
| Dec 13, 1995 | Original application | Approved | None posted |
| May 15, 2018 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jun 16, 2004 | Supplement 11Labeling | Approved | None posted |
| Jun 6, 2002 | Supplement 6Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 4Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 5Manufacturing | Approved | None posted |
| Dec 5, 1997 | Supplement 3Manufacturing | Approved | None posted |
| Feb 24, 1997 | Supplement 2Manufacturing | Approved | None posted |
| May 28, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Dec 13, 1995 | 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
