Zolymbus
NDA 217307, held by Thea Pharma. Bimatoprost.
- First approved: Sep 9, 2025
- Review: Standard
- Supplements approved: 0
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 9, 2025 | Original applicationNew dosage form · Standard review | Approved |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Zolymbus0.01% · gel;ophthalmic | Bimatoprost | Rx · reference drug |
Identifiers
- Application
- NDA 217307
- Drugs@FDA
- Overview at FDA
- Company
- Thea Pharma
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters