NDA 022134

ALLERGAN

FDA Drug Application

Application #022134

Documents

• Letter: 2015-10-02
• Label: 2015-10-07
• Review: 2010-08-23
• Summary Review: 2011-02-17
• Letter: 2010-07-30
• Letter: 2014-12-05
• Label: 2010-07-31
• Label: 2014-12-10
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2020-06-10
• Label: 2020-06-12
• Label: 2021-12-13
• Letter: 2021-12-15
• Letter: 2022-08-30

Application Sponsors

NDA 022134

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.25%

1

LASTACAFT

ALCAFTADINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2010-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2014-08-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-07-25	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-09-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-06-09	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	2021-12-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-08-29	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22134
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LASTACAFT","activeIngredients":"ALCAFTADINE","strength":"0.25%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/09\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022134s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022134s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022134s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022134s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LASTACAFT","submission":"ALCAFTADINE","actionType":"0.25%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-06-09
        )

)