Approvals and New Uses
The original application and every efficacy supplement, newest first; all 5 submissions below| Date | Submission | Status | Documents |
|---|
| Feb 20, 2015 | Original application | Approved | None posted |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Bimatoprost0.03% · solution/drops;ophthalmic | Bimatoprost | Discontinued |
All 5 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Nov 2, 2022 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 2, 2022 | Supplement 11Labeling · Standard review | Approved | None posted |
| Nov 2, 2022 | Supplement 14Labeling · Standard review | Approved | None posted |
| Nov 24, 2020 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Feb 20, 2015 | Original application | Approved | None posted |
Identifiers
- Application
- ANDA 203991
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
