NDA 022184

ALLERGAN

FDA Drug Application

Application #022184

Documents

• Letter: 2010-09-02
• Label: 2010-09-07
• Label: 2012-03-16
• Review: 2010-12-08
• Letter: 2012-03-19
• Letter: 2014-10-02
• Label: 2014-09-30
• Summary Review: 2011-02-17
• Label: 2017-07-29
• Letter: 2017-08-02
• Letter: 2020-09-30
• Label: 2020-10-01
• Letter: 2022-03-09
• Label: 2022-03-11

Application Sponsors

NDA 022184

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.01%

1

LUMIGAN

BIMATOPROST

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2010-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2013-07-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-09-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-09-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2017-07-29	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-09-29	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-03-08	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	7
SUPPL	6	Null	33
SUPPL	8	Null	7
SUPPL	9	Null	15

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22184
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUMIGAN","activeIngredients":"BIMATOPROST","strength":"0.01%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/29\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022184s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022184s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022184s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022184s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LUMIGAN","submission":"BIMATOPROST","actionType":"0.01%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-07-29
        )

)