ANDA 72641, held by Sun Pharma Canada. Clotrimazole.
As of Nov 15, 2026, ANDA 72641 (Clotrimazole), held by Sun Pharma Canada, was first approved by FDA on Dec 4, 1995, with 16 approved supplements and 0 published complete response letters.
Uses
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 4, 1995 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clotrimazole1% · cream;vaginal | Clotrimazole | OTC |
| Nov 4, 2002 | Supplement 18Manufacturing | Approved | None posted |
| Oct 15, 2001 | Supplement 17Manufacturing | Approved | None posted |
| Oct 15, 2001 | Supplement 16Manufacturing | Approved | None posted |
| Nov 20, 2000 | Supplement 15Manufacturing | Approved | None posted |
| Nov 20, 2000 | Supplement 14Manufacturing | Approved | None posted |
| Mar 14, 2000 | Supplement 13Manufacturing | Approved | None posted |
| Mar 14, 2000 | Supplement 12Manufacturing | Approved | None posted |
| Mar 14, 2000 | Supplement 11Manufacturing | Approved | None posted |
| Mar 14, 2000 | Supplement 10Manufacturing | Approved | None posted |
| Jan 29, 1998 | Supplement 9Manufacturing | Approved | None posted |
| Dec 8, 1997 | Supplement 8Manufacturing | Approved | None posted |
| Sep 30, 1997 | Supplement 6Manufacturing | Approved | None posted |
| Mar 25, 1997 | Supplement 4Manufacturing | Approved | None posted |
| Mar 25, 1997 | Supplement 3Manufacturing | Approved | None posted |
| Jan 7, 1997 | Supplement 2Manufacturing | Approved | None posted |
| Sep 17, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Dec 4, 1995 | 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
