Treats hypertension. ANDA 74677, held by Andas 5 Holding. Captopril.
As of Nov 13, 2026, ANDA 74677 (Captopril), held by Andas 5 Holding, was first approved by FDA on May 30, 1997, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hypertension Captopril tablets are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets 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 |
|---|---|---|---|
| May 30, 1997 | 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
