Treats edema associated with congestive heart failure, cirrhosis … the nephrotic syndrome. NDA 13174, held by Advanz Pharma. Triamterene.
As of Nov 13, 2026, NDA 13174 (Dyrenium), held by Advanz Pharma, was first approved by FDA on Aug 10, 1964, with 39 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 |
|---|---|---|---|
| Aug 10, 1964 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dyrenium50MG · capsule;oral | Triamterene | RxReference drug |
| Dyrenium100MG · capsule;oral | Triamterene | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2002 | Supplement 59Manufacturing · Priority review | Approved | None posted |
| Sep 13, 1994 | Supplement 58Labeling · Standard review | Approved | None posted |
| Dec 9, 1992 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| Jun 3, 1992 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Mar 7, 1990 | Supplement 54Labeling | Approved | None posted |
| Nov 9, 1988 | Supplement 53Labeling | Approved | None posted |
| Feb 2, 1988 | Supplement 52Manufacturing · Priority review | Approved | None posted |
| Sep 29, 1987 | Supplement 51Labeling | Approved | None posted |
| Sep 23, 1987 | Supplement 50Manufacturing · Priority review | Approved | None posted |
| Oct 4, 1985 | Supplement 45Labeling | Approved | None posted |
| Aug 25, 1982 | Supplement 46Labeling | Approved | None posted |
| Feb 5, 1981 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Jul 14, 1980 | Supplement 44Labeling | Approved | None posted |
| Nov 26, 1979 | Supplement 43Labeling | Approved | None posted |
| Nov 12, 1979 | Supplement 41Labeling | Approved | None posted |
| Aug 7, 1979 | Supplement 39Labeling | Approved | None posted |
| Nov 16, 1978 | Supplement 37Labeling | Approved | None posted |
| Aug 15, 1978 | Supplement 36Labeling | Approved | None posted |
| May 22, 1978 | Supplement 30Labeling | Approved | None posted |
| May 22, 1978 | Supplement 29Labeling | Approved | None posted |
| Feb 17, 1978 | Supplement 31Labeling | Approved | None posted |
| Jan 19, 1978 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Jan 19, 1978 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Jan 19, 1978 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Dec 12, 1977 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Apr 1, 1977 | Supplement 26Labeling | Approved | None posted |
| Feb 14, 1977 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Feb 14, 1977 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Nov 5, 1976 | Supplement 24Labeling | Approved | None posted |
| Sep 3, 1976 | Supplement 23Labeling | Approved | None posted |
| Sep 3, 1976 | Supplement 22Labeling | Approved | None posted |
| Sep 3, 1976 | Supplement 20Labeling | Approved | None posted |
| Jan 14, 1976 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Jan 14, 1976 | Supplement 19Labeling | Approved | None posted |
| Jan 14, 1976 | Supplement 16REMS · Priority review | Approved | None posted |
| Jul 24, 1975 | Supplement 14REMS · Priority review | Approved | None posted |
| Jun 2, 1975 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Jun 2, 1975 | Supplement 17Labeling | Approved | None posted |
| Jun 2, 1975 | Supplement 11REMS · Priority review | Approved | None posted |
| Aug 10, 1964 | Original applicationNew molecular entity · Priority review | 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
