NDA 021009

ALLERGAN

FDA Drug Application

Application #021009

Documents

• Letter: 2002-03-08
• Letter: 2007-08-22
• Letter: 2004-10-22
• Label: 1999-12-08
• Label: 2007-08-22
• Letter: 1999-12-08
• Letter: 2007-08-22
• Letter: 2004-10-22
• Letter: 2008-07-08
• Label: 2007-08-22
• Label: 2008-07-09
• Review: 2004-05-26

Application Sponsors

NDA 021009

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

2%

1

ALOCRIL

NEDOCROMIL SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1999-12-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-03-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2007-08-21	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2007-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2004-10-18	PRIORITY
LABELING; Labeling	SUPPL	9	AP	2004-10-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	2008-07-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2016-01-13	PRIORITY

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0

TE Codes

001

Prescription

AT

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21009
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALOCRIL","activeIngredients":"NEDOCROMIL SODIUM","strength":"2%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/07\/2008","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021009s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2007","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021009s003s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2007","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021009s003s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/21009lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALOCRIL","submission":"NEDOCROMIL SODIUM","actionType":"2%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2008-07-07
        )

)