Approvals and New Uses
The original application and every efficacy supplement, newest first; all 4 submissions below| Date | Submission | Status | Documents |
|---|
| Jun 19, 2019 | Original application | Approved | None posted |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Bimatoprost0.03% · solution/drops;ophthalmic | Bimatoprost | Rx |
All 4 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Dec 20, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 20, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 20, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 19, 2019 | Original application | Approved | None posted |
Identifiers
- Application
- ANDA 207601
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
