← FDA DRUG APPROVALS

FDA BLA · BLA020725

CREON

pancrelipase

Sponsor: ABBVIE

APPLICATION
BLA020725
TYPE
BLA
ORIGINAL APPROVAL
2009-04-30
LATEST ACTION
2024-02-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

CREONPrescription
PANCRELIPASE (AMYLASE 15,000USP UNITS, LIPASE 3,000USP UNITS, PROTEASE) 9,500USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
CREONPrescription
PANCRELIPASE (AMYLASE 60,000USP UNITS, LIPASE 12,000USP UNITS, PROTEASE) 38,000USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
CREONPrescription
PANCRELIPASE (AMYLASE 180,000USP UNITS, LIPASE 36,000USP UNITS, PROTEASE) 114,000USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
CREONPrescription
PANCRELIPASE (AMYLASE 120,000USP UNITS, LIPASE 24,000USP UNITS, PROTEASE) 76,000USP UNITS · CAPSULE, DELAYED RELEASE · ORAL
CREONPrescription
PANCRELIPASE (AMYLASE 30,000USP UNITS, LIPASE 6,000USP UNITS, PROTEASE) 19,000USP UNITS · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-02-28Labeling · Supplement 31 · standard — Letter ↗AP
2022-06-02Labeling · Supplement 28 · standard — Letter ↗AP
2020-03-20Labeling · Supplement 26 · standard — Label ↗AP
2019-05-09Labeling · Supplement 25 · standard — Letter ↗AP
2016-06-16Manufacturing (CMC) · Supplement 23 · priorityAP
2015-04-10Manufacturing (CMC) · Supplement 22 · priorityAP
2015-01-05Manufacturing (CMC) · Supplement 21 · priorityAP
2014-11-21Manufacturing (CMC) · Supplement 18 · priorityAP
2014-11-19Manufacturing (CMC) · Supplement 20 · priorityAP
2014-03-17Manufacturing (CMC) · Supplement 9 · priorityAP
2013-03-14Manufacturing (CMC) · Supplement 16 · priority — Label ↗AP
2013-02-28Manufacturing (CMC) · Supplement 17 · priorityAP
2012-11-20Manufacturing (CMC) · Supplement 15 · priorityAP
2011-07-12Efficacy · Supplement 8 · standard — Label ↗AP
2011-06-10Manufacturing (CMC) · Supplement 11 · priority — Pediatric Clinical Pharmacology Review ↗AP
2011-05-09REMS · Supplement 14 — Letter ↗AP
2010-08-12REMS · Supplement 7 — Label ↗AP
2010-07-29Efficacy · Supplement 6 · standard — Letter ↗AP
2010-04-30Efficacy · Supplement 3 · standard — Label ↗AP
2009-04-30Type 7 - Drug Already Marketed without Approved NDA · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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