ANDA 207524, held by Somerset Theraps LLC. Tropicamide.
As of Nov 15, 2026, ANDA 207524 (Tropicamide), held by Somerset Theraps LLC, was first approved by FDA on Dec 12, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 12, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tropicamide1% · solution/drops;ophthalmic | Tropicamide | Rx |
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
