Approvals and New Uses
The original application and every efficacy supplement, newest first; all 18 submissions below| Date | Submission | Status | Documents |
|---|
| Jun 22, 2006 | Supplement 13Efficacy (new indication or use) | Approved | ReviewLabelLetter |
| Mar 16, 2001 | Original applicationNew molecular entity · Priority review | Approved | LetterReviewLabel |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Lumigan0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution/drops;ophthalmic | Bimatoprost | Discontinued · reference drug |
All 18 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Mar 8, 2022 | Supplement 29Labeling · Standard review | Approved | LabelLetter |
| Oct 15, 2020 | Supplement 28Labeling · Standard review | Approved | LetterLabel |
| Jul 29, 2017 | Supplement 27Labeling · Standard review | Approved | LetterLabel |
| Sep 29, 2014 | Supplement 26Labeling · Standard review | Approved | LetterLabel |
| Feb 28, 2013 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Mar 15, 2012 | Supplement 23Labeling | Approved | LetterLabel |
| Mar 11, 2011 | Supplement 22Labeling | Approved | Label |
| Mar 11, 2011 | Supplement 11Labeling · Standard review | Approved | Label |
| Jun 22, 2006 | Supplement 13Efficacy (new indication or use) | Approved | ReviewLabelLetter |
| Nov 10, 2003 | Supplement 15Labeling · Standard review | Approved | LabelLetter |
| Nov 10, 2003 | Supplement 14Manufacturing · Priority review | Approved | LabelLetter |
| Aug 25, 2003 | Supplement 12Labeling · Standard review | Approved | LetterLabel |
| Aug 25, 2003 | Supplement 10Manufacturing · Priority review | Approved | LabelLetter |
| Aug 26, 2002 | Supplement 6Labeling · Standard review | Approved | LabelLetter |
| Apr 17, 2002 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Apr 12, 2002 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Aug 7, 2001 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Mar 16, 2001 | Original applicationNew molecular entity · Priority review | Approved | LetterReviewLabel |
Identifiers
- Application
- NDA 21275
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
