ABBVIE FDA Approval BLA 020725

BLA 020725

ABBVIE

FDA Drug Application

Application #020725

Documents

Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Other2020-03-23
Label2020-03-23
Medication Guide2020-03-23
Letter2020-03-23
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Other2020-03-23
Pediatric Medical Review1900-01-01
Letter2022-06-03
Label2022-06-07
Medication Guide2022-06-07

Application Sponsors

BLA 020725ABBVIE

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001CAPSULE, DELAYED RELEASE;ORAL30,000USP UNITS;6,000USP UNITS;19,000USP UNITS0CREONPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
002CAPSULE, DELAYED RELEASE;ORAL60,000USP UNITS;12,000USP UNITS;38,000USP UNITS0CREONPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
003CAPSULE, DELAYED RELEASE;ORAL120,000USP UNITS;24,000USP UNITS;76,000USP UNITS0CREONPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
004CAPSULE, DELAYED RELEASE;ORAL15,000USP UNITS;3,000USP UNITS;9,500USP UNITS0CREONPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
005CAPSULE, DELAYED RELEASE;ORAL180,000USP UNITS;36,000USP UNITS;114,000USP UNITS0CREONPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDAORIG1AP2009-04-30PRIORITY
EFFICACY; EfficacySUPPL3AP2010-04-30STANDARD
EFFICACY; EfficacySUPPL6AP2010-07-29STANDARD
REMS; REMSSUPPL7AP2010-08-12N/A
EFFICACY; EfficacySUPPL8AP2011-07-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2014-03-17PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2011-06-10PRIORITY
REMS; REMSSUPPL14AP2011-05-09N/A
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2012-11-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2013-03-14PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2013-02-28PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2014-11-21PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2014-11-19PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2015-01-05PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2015-04-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2016-06-16PRIORITY
LABELING; LabelingSUPPL25AP2019-05-09STANDARD
LABELING; LabelingSUPPL26AP2020-03-20STANDARD
LABELING; LabelingSUPPL28AP2022-06-02STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null31
SUPPL6Null7
SUPPL7Null7
SUPPL8Null31
SUPPL9Null0
SUPPL11Null0
SUPPL14Null7
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0
SUPPL23Null0
SUPPL25Null15
SUPPL26Null33
SUPPL28Null7

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20725
            [companyName] => ABBVIE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/020725s026lbl.pdf#page=16"]
            [products] => [{"drugName":"CREON","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"30,000USP UNITS;6,000USP UNITS;19,000USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CREON","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"60,000USP UNITS;12,000USP UNITS;38,000USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CREON","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"120,000USP UNITS;24,000USP UNITS;76,000USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CREON","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"15,000USP UNITS;3,000USP UNITS;9,500USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CREON","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"180,000USP UNITS;36,000USP UNITS;114,000USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/20\/2020","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020725s026lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CREON","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"30,000USP UNITS;6,000USP UNITS;19,000USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CREON","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"60,000USP UNITS;12,000USP UNITS;38,000USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CREON","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"120,000USP UNITS;24,000USP UNITS;76,000USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CREON","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"15,000USP UNITS;3,000USP UNITS;9,500USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CREON","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"180,000USP UNITS;36,000USP UNITS;114,000USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-03-20
        )

)
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