NDA 021565

ALLERGAN

FDA Drug Application

Application #021565

Documents

• Letter: 2003-10-14
• Label: 2003-10-17
• Label: 2011-12-23
• Letter: 2005-08-19
• Letter: 2011-12-22
• Label: 2005-08-16
• Review: 2003-12-31

Application Sponsors

NDA 021565

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.05%

1

ELESTAT

EPINASTINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2003-10-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2005-08-15	STANDARD
LABELING; Labeling	SUPPL	6	AP	2011-12-20	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2013-06-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2016-02-25	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	15
SUPPL	7	Null	0
SUPPL	8	Null	0

TE Codes

001

Prescription

AT

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21565
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELESTAT","activeIngredients":"EPINASTINE HYDROCHLORIDE","strength":"0.05%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/20\/2011","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021565s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2005","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021565s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21565_elestat_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ELESTAT","submission":"EPINASTINE HYDROCHLORIDE","actionType":"0.05%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-12-20
        )

)