NDA 020547

PAR PHARM INC

FDA Drug Application

Application #020547

Documents

• Letter: 1999-09-17
• Letter: 2003-07-29
• Letter: 2009-11-19
• Letter: 2010-10-19
• Label: 2009-08-28
• Label: 2010-07-19
• Label: 2011-08-08
• Review: 2004-04-14
• Review: 2004-05-25
• Letter: 2004-05-25
• Letter: 2005-06-08
• Letter: 2008-06-02
• Letter: 2010-07-15
• Letter: 2011-08-10
• Letter: 2013-11-18
• Label: 2004-04-05
• Label: 2005-06-08
• Label: 2010-10-19
• Label: 2013-11-22
• Review: 2004-05-25
• Review: 1997-04-10

Application Sponsors

NDA 020547

PAR PHARM INC

Marketing Status

• Prescription: 001
• Prescription: 003

Application Products

001	TABLET;ORAL	20MG	1	ACCOLATE	ZAFIRLUKAST
003	TABLET;ORAL	10MG	1	ACCOLATE	ZAFIRLUKAST

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-09-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	1997-07-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-05-06	STANDARD
LABELING; Labeling	SUPPL	4	AP	1998-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-05-06	STANDARD
LABELING; Labeling	SUPPL	6	AP	1998-08-17	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	1999-09-17	STANDARD
LABELING; Labeling	SUPPL	8	AP	1999-03-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-04-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-09-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2000-02-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-11-12	STANDARD
LABELING; Labeling	SUPPL	13	AP	2000-06-12	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2001-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-09-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-01-08	STANDARD
LABELING; Labeling	SUPPL	17	AP	2003-10-31	STANDARD
LABELING; Labeling	SUPPL	19	AP	2004-03-26	STANDARD
LABELING; Labeling	SUPPL	22	AP	2005-06-06	STANDARD
LABELING; Labeling	SUPPL	25	AP	2008-05-29	STANDARD
LABELING; Labeling	SUPPL	27	AP	2009-08-21	STANDARD
LABELING; Labeling	SUPPL	29	AP	2010-07-14	UNKNOWN
LABELING; Labeling	SUPPL	30	AP	2010-10-13	UNKNOWN
LABELING; Labeling	SUPPL	31	AP	2011-08-08	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2013-05-15	STANDARD
LABELING; Labeling	SUPPL	33	AP	2013-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2016-03-29	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	27	Null	6
SUPPL	29	Null	7
SUPPL	30	Null	6
SUPPL	31	Null	6
SUPPL	32	Null	0
SUPPL	33	Null	15
SUPPL	34	Null	0

TE Codes

001	Prescription	AB
003	Prescription	AB

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20547
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACCOLATE","activeIngredients":"ZAFIRLUKAST","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ACCOLATE","activeIngredients":"ZAFIRLUKAST","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/15\/2013","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020547s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/08\/2011","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020547s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2010","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020547s030lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2010","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020547s029lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2009","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020547s027lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2005","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020547s022lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2004","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20547slr019_accolate_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ACCOLATE","submission":"ZAFIRLUKAST","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ACCOLATE","submission":"ZAFIRLUKAST","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-11-15
        )

)