ANDA 40064, held by Bausch And Lomb. Tropicamide.
As of Nov 15, 2026, ANDA 40064 (Tropicamide), held by Bausch And Lomb, was first approved by FDA on Jul 27, 1994, with 13 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 27, 1994 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tropicamide1% · solution/drops;ophthalmic | Tropicamide | Rx |
| Nov 13, 2015 | Supplement 24Labeling · Standard review | Approved | None posted |
| Nov 27, 2001 | Supplement 12Manufacturing | Approved | None posted |
| Mar 7, 2001 | Supplement 11Manufacturing | Approved | None posted |
| Oct 5, 2000 | Supplement 10Manufacturing | Approved | None posted |
| Jun 27, 2000 | Supplement 9Manufacturing | Approved | None posted |
| Jun 2, 2000 | Supplement 3Manufacturing | Approved | None posted |
| May 18, 2000 | Supplement 6Manufacturing | Approved | None posted |
| May 15, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Apr 28, 2000 | Supplement 7Manufacturing | Approved | None posted |
| Jun 7, 1999 | Supplement 5Manufacturing | Approved | None posted |
| Nov 19, 1998 | Supplement 4Manufacturing | Approved | None posted |
| Feb 10, 1998 | Supplement 2Manufacturing | Approved | None posted |
| Jan 22, 1997 | Supplement 1Manufacturing | Approved | None posted |
| Jul 27, 1994 | 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
