NDA 20506, held by Merck. Diltiazem Malate.
As of Nov 13, 2026, NDA 20506 (Tiamate), held by Merck, was first approved by FDA on Oct 4, 1996, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 4, 1996 | Original applicationNew active ingredient · Standard review | Approved | None posted |
| TiamateEQ 120MG HYDROCHLORIDE · tablet, extended release;oral | Diltiazem Malate | Discontinued |
| TiamateEQ 180MG HYDROCHLORIDE · tablet, extended release;oral | Diltiazem Malate | Discontinued |
| TiamateEQ 240MG HYDROCHLORIDE · tablet, extended release;oral | Diltiazem Malate | Discontinued |
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