Documents
Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;TOPICAL | 0.03% | 1 | LATISSE | BIMATOPROST |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2008-12-24 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2011-09-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 2011-09-07 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2012-03-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2013-01-31 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2013-03-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 2014-09-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2013-11-01 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2014-09-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 2017-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2020-09-29 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2021-08-26 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 14 | Null | 7 |
TE Codes
CDER Filings
ALLERGAN
cder:Array
(
[0] => Array
(
[ApplNo] => 22369
[companyName] => ALLERGAN
[docInserts] => ["",""]
[products] => [{"drugName":"LATISSE","activeIngredients":"BIMATOPROST","strength":"0.03%","dosageForm":"SOLUTION\/DROPS;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/29\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022369s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2014","submission":"SUPPL-10","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022369s008s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2014","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022369s008s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2013","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022369s007lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"03\/29\/2012","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022369s005lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"09\/07\/2011","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022369s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/24\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022369lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"LATISSE","submission":"BIMATOPROST","actionType":"0.03%","submissionClassification":"SOLUTION\/DROPS;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-07-29
)
)