Treats hypertension. ANDA 74737, held by Macleods Pharms. Captopril.
As of Nov 14, 2026, ANDA 74737 (Captopril), held by Macleods Pharms, was first approved by FDA on Oct 28, 1998, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hypertension: Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 1998 | Original application | Approved |
| Jul 8, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Mar 3, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Feb 16, 2016 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 16, 2016 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 20, 2015 | Supplement 8Labeling · Standard review | Approved | None posted |
| Apr 8, 2011 | Supplement 7Labeling | Approved | None posted |
| Nov 13, 2007 | Supplement 5Labeling | Approved | None posted |
| Oct 28, 1998 | Original application | Approved |
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
