Approvals and New Uses
The original application and every efficacy supplement, newest first; all 12 submissions belowProducts
1 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Latisse0.03% · solution/drops;topical | Bimatoprost | Rx · reference drug |
All 12 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Aug 26, 2021 | Supplement 14Labeling · Standard review | Approved | LabelLetter |
| Sep 29, 2020 | Supplement 12Labeling · Standard review | Approved | LabelLetter |
| Jul 29, 2017 | Supplement 11Labeling · Standard review | Approved | LetterLabel |
| Sep 4, 2014 | Supplement 8Labeling · Standard review | Approved | LabelLetterPediatric DD Summary ReviewPediatric CDTL Review |
| Sep 4, 2014 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | LabelLetterPediatric DD Summary ReviewPediatric CDTL Review |
| Nov 1, 2013 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Mar 13, 2013 | Supplement 7Manufacturing · Priority review | Approved | Label |
| Jan 31, 2013 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Mar 29, 2012 | Supplement 5Manufacturing · Priority review | Approved | Label |
| Sep 7, 2011 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Sep 7, 2011 | Supplement 4Labeling | Approved | LabelLetter |
| Dec 24, 2008 | Original applicationNew formulation or manufacturer · Priority review | Approved | ReviewSummary ReviewLabelLetter |
Identifiers
- Application
- NDA 22369
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
