Approvals and New Uses
The original application and every efficacy supplement, newest first; all 8 submissions belowProducts
1 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Lumigan0.01% · solution/drops;ophthalmic | Bimatoprost | Rx · reference drug |
All 8 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Mar 8, 2022 | Supplement 9Labeling · Standard review | Approved | LabelLetter |
| Sep 29, 2020 | Supplement 8Labeling · Standard review | Approved | LabelLetter |
| Jul 29, 2017 | Supplement 6Labeling · Standard review | Approved | LetterLabel |
| Sep 29, 2014 | Supplement 5Labeling · Standard review | Approved | LetterLabel |
| Sep 19, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 22, 2013 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 15, 2012 | Supplement 1Labeling | Approved | LetterLabel |
| Aug 31, 2010 | Original applicationNew formulation or manufacturer · Standard review | Approved | Summary ReviewReviewLabelLetter |
Identifiers
- Application
- NDA 22184
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
