NDA 18869, held by Bayer Pharms. Nimodipine.
As of Nov 13, 2026, NDA 18869 (Nimotop), held by Bayer Pharms, was first approved by FDA on Dec 28, 1988, with 12 approved supplements and 0 published complete response letters.
| Aug 22, 2000 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Dec 28, 1988 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nimotop30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Nimodipine | DiscontinuedReference drug |
| Jan 20, 2006 | Supplement 14Labeling · Priority review | Approved | |
| Aug 22, 2000 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Aug 21, 2000 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Dec 15, 1999 | Supplement 9Labeling · Priority review | Approved | None posted |
| Apr 18, 1997 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Oct 24, 1996 | Supplement 7Labeling · Priority review | Approved | None posted |
| Sep 2, 1994 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Apr 16, 1993 | Supplement 5Labeling · Priority review | Approved | None posted |
| Aug 12, 1991 | Supplement 4Labeling · Priority review | Approved | None posted |
| Dec 7, 1990 | Supplement 3Labeling · Priority review | Approved | None posted |
| Oct 26, 1989 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Apr 24, 1989 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Dec 28, 1988 | 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
