ANDA 84505, held by Sun Pharm Industries. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 84505 (Dicyclomine Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Jun 23, 1975, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 1975 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dicyclomine Hydrochloride10MG ยท capsule;oral | Dicyclomine Hydrochloride | Discontinued |
| Dec 1, 1998 | Supplement 60Manufacturing | Approved | None posted |
| Mar 9, 1998 | Supplement 59Labeling | Approved | None posted |
| Dec 23, 1994 | Supplement 58Manufacturing | Approved | None posted |
| Oct 11, 1994 | Supplement 57Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 56Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 54Manufacturing | Approved | None posted |
| Dec 18, 1990 | Supplement 53Labeling | Approved | None posted |
| Oct 31, 1990 | Supplement 51Labeling | Approved | None posted |
| Jun 8, 1989 | Supplement 49Labeling | Approved | None posted |
| Mar 20, 1987 | Supplement 47Manufacturing | Approved | None posted |
| May 15, 1986 | Supplement 45Manufacturing | Approved | None posted |
| May 15, 1986 | Supplement 44Manufacturing | Approved | None posted |
| May 15, 1986 | Supplement 43Manufacturing | Approved | None posted |
| May 15, 1986 | Supplement 42Manufacturing | Approved | None posted |
| Jun 23, 1975 | Original application | 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
