NDA 021079

SANTEN

FDA Drug Application

Application #021079

Documents

• Letter: 1999-09-24
• Review: 2004-05-26
• Letter: 2005-05-17
• Letter: 2005-05-17
• Label: 1999-09-24
• Label: 2005-05-17
• Label: 2005-05-17

Application Sponsors

NDA 021079

SANTEN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.1%

0

ALAMAST

PEMIROLAST POTASSIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1999-09-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-12-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-02-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-05-03	PRIORITY
LABELING; Labeling	SUPPL	6	AP	2005-05-12	STANDARD
LABELING; Labeling	SUPPL	8	AP	2005-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2013-02-15	PRIORITY

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	14	Null	0

CDER Filings

SANTEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21079
            [companyName] => SANTEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALAMAST","activeIngredients":"PEMIROLAST POTASSIUM","strength":"0.1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/12\/2005","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021079s006,008lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2005","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021079s006,008lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21079lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALAMAST","submission":"PEMIROLAST POTASSIUM","actionType":"0.1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2005-05-12
        )

)