Treats edema associated with congestive heart failure, cirrhosis … the nephrotic syndrome. ANDA 220782, held by Rubicon Research. Triamterene.
As of Nov 15, 2026, ANDA 220782 (Triamterene), held by Rubicon Research, was first approved by FDA on Oct 28, 2026, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Triamterene Capsules are indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid- induced edema, idiopathic edema and edema due to secondary hyperaldosteronism. Triamterene Capsules may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. It also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism. Usage in Pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 2026 | Original application | Approved | None posted |
| Triamterene50MG · capsule;oral | Triamterene | Rx |
| Triamterene100MG · capsule;oral | Triamterene | Rx |
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
