NDA 021324

PERRIGO PHARMA INTL

FDA Drug Application

Application #021324

Documents

• Letter: 2004-06-03
• Letter: 2003-03-26
• Letter: 2005-05-03
• Letter: 2009-06-24
• Letter: 2016-05-03
• Label: 2009-06-24
• Label: 2011-12-23
• Label: 2016-05-03
• Review: 2001-10-02
• Patient Package Insert: 2003-05-07
• Letter: 2001-10-02
• Letter: 2004-06-03
• Letter: 2011-12-22
• Letter: 2016-05-03
• Label: 2001-10-02
• Label: 2005-05-03
• Label: 2016-05-03
• Label: 2017-10-19
• Letter: 2017-10-19
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2019-01-22
• Letter: 2019-01-22
• Review: 2009-06-22
• Review: 2019-01-18
• Label: 2020-07-15
• Letter: 2020-07-17

Application Sponsors

NDA 021324

PERRIGO PHARMA INTL

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

3MG

1

ENTOCORT EC

BUDESONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2001-10-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-08-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-10-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2003-03-13	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2005-04-29	UNKNOWN
LABELING; Labeling	SUPPL	8	AP	2009-06-22	STANDARD
LABELING; Labeling	SUPPL	9	AP	2011-12-20	UNKNOWN
EFFICACY; Efficacy	SUPPL	12	AP	2016-04-29	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2016-04-29	STANDARD
LABELING; Labeling	SUPPL	16	AP	2017-10-17	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-01-18	STANDARD
LABELING; Labeling	SUPPL	23	AP	2020-07-15	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	9	Null	15
SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	16	Null	7
SUPPL	18	Null	6
SUPPL	23	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO PHARMA INTL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21324
            [companyName] => PERRIGO PHARMA INTL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENTOCORT EC","activeIngredients":"BUDESONIDE","strength":"3MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/15\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021324Orig1s023lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021324Orig1s023lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021324Orig1s023lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021324s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021324s016lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2016","submission":"SUPPL-13","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021324s012s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2016","submission":"SUPPL-12","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021324s012s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2011","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021324s009lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2009","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021324s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2005","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021324s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21324lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ENTOCORT EC","submission":"BUDESONIDE","actionType":"3MG","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-07-15
        )

)