NDA 18485, held by Mt Adams. Verapamil Hydrochloride.
As of Nov 13, 2026, NDA 18485 (Isoptin), held by Mt Adams, was first approved by FDA on Aug 12, 1981, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 12, 1981 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Isoptin2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Verapamil Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 11, 1998 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Mar 7, 1994 | Supplement 9Labeling · Standard review | Approved | |
| Sep 16, 1992 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Jun 16, 1987 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Oct 8, 1986 | Supplement 7Labeling | Approved | None posted |
| Dec 18, 1985 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Aug 21, 1984 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Apr 12, 1984 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Apr 12, 1984 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Aug 12, 1981 | 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
