NDA 021479

BAUSCH

FDA Drug Application

Application #021479

Documents

• Letter: 2009-01-06
• Letter: 2014-08-01
• Label: 2006-06-20
• Label: 2009-01-06
• Label: 2014-08-19
• Review: 2009-01-15
• Letter: 2006-06-20
• Letter: 2009-01-06
• Label: 2009-01-06
• Letter: 2019-08-20
• Label: 2021-06-17
• Letter: 2021-06-17

Application Sponsors

NDA 021479

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING;ORAL

1.25MG

1

ZELAPAR

SELEGILINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2006-06-14	STANDARD
LABELING; Labeling	SUPPL	3	AP	2008-12-31	STANDARD
LABELING; Labeling	SUPPL	4	AP	2008-12-31	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2015-10-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-08-19	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-06-16	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	5	Null	6
SUPPL	7	Null	0
SUPPL	8	Null	15
SUPPL	10	Null	6

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21479
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZELAPAR","activeIngredients":"SELEGILINE HYDROCHLORIDE","strength":"1.25MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/31\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021479s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2008","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021479s003s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2008","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021479s003s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021479lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZELAPAR","submission":"SELEGILINE HYDROCHLORIDE","actionType":"1.25MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-07-31
        )

)