NDA 8848, held by Fougera. Methscopolamine Bromide.
As of Nov 14, 2026, NDA 8848 (Pamine, Pamine Forte), held by Fougera, was first approved by FDA on Apr 9, 1953, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 9, 1953 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Pamine2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Methscopolamine Bromide | Discontinued |
| Pamine Forte5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Methscopolamine Bromide | Discontinued |
| May 16, 2005 | Supplement 25Manufacturing · Standard review | Approved | |
| Mar 25, 2003 | Supplement 24Manufacturing · Standard review | Approved | |
| Jun 22, 2001 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1999 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1999 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Oct 24, 1997 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1989 | Supplement 17Labeling | Approved | None posted |
| Sep 4, 1986 | Supplement 18Labeling | Approved | |
| Nov 28, 1980 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1980 | Supplement 15Labeling | Approved | None posted |
| Nov 28, 1980 | Supplement 16 | Approved | None posted |
| Apr 9, 1953 | Original applicationNew molecular entity · Standard 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
