NDA 7961, held by Aptalis Pharma US. Dicyclomine Hydrochloride.
As of Nov 13, 2026, NDA 7961 (Bentyl), held by Aptalis Pharma US, was first approved by FDA on Apr 30, 1951, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 1951 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bentyl10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · syrup;oral | Dicyclomine Hydrochloride | DiscontinuedReference drug |
| Aug 1, 2011 | Supplement 28Labeling | Approved | |
| Feb 2, 2007 | Supplement 26Labeling · Standard review | Approved | |
| Aug 17, 1999 | Supplement 25Labeling · Standard review | Approved | None posted |
| Sep 9, 1996 | Supplement 24Labeling · Standard review | Approved | None posted |
| Jan 4, 1993 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Sep 25, 1990 | Supplement 23Labeling | Approved | None posted |
| Aug 4, 1989 | Supplement 11Labeling | Approved | None posted |
| Feb 6, 1987 | Supplement 21Labeling | Approved | None posted |
| Jun 12, 1985 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| May 13, 1985 | Supplement 19Labeling | Approved | None posted |
| Oct 15, 1984 | Supplement 16Labeling | Approved | None posted |
| Oct 15, 1984 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 30, 1951 | Original applicationNew dosage form · 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
