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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020725
Company: ABBVIE

Medication Guide

Summary Review

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 020725

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CREON	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	30,000USP UNITS;6,000USP UNITS;19,000USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
CREON	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	60,000USP UNITS;12,000USP UNITS;38,000USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
CREON	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	120,000USP UNITS;24,000USP UNITS;76,000USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
CREON	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	15,000USP UNITS;3,000USP UNITS;9,500USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
CREON	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	180,000USP UNITS;36,000USP UNITS;114,000USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 020725

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2009	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020725s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020725s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020725_creon_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020725s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2024	SUPPL-31	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020725s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020725Orig1s031ltr.pdf
06/02/2022	SUPPL-28	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020725s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020725Orig1s028ltr.pdf
03/20/2020	SUPPL-26	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020725s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020725Orig1s026ltr.pdf
05/09/2019	SUPPL-25	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020725Orig1s025ltr.pdf
06/16/2016	SUPPL-23	Supplement		Label is not available on this site.
04/10/2015	SUPPL-22	Supplement		Label is not available on this site.
01/05/2015	SUPPL-21	Supplement		Label is not available on this site.
11/19/2014	SUPPL-20	Supplement		Label is not available on this site.
11/21/2014	SUPPL-18	Supplement		Label is not available on this site.
02/28/2013	SUPPL-17	Supplement		Label is not available on this site.
03/14/2013	SUPPL-16	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020725s016lbl.pdf
11/20/2012	SUPPL-15	Supplement		Label is not available on this site.
05/09/2011	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020725s014ltr.pdf
06/10/2011	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020725s011ltr.pdf
03/17/2014	SUPPL-9	Supplement		Label is not available on this site.
07/12/2011	SUPPL-8	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s008lbl.pdf
08/12/2010	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020725s007ltr.pdf
07/29/2010	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020725s006ltr.pdf
04/30/2010	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020725s003ltr.pdf

Labels for BLA 020725

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2024	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020725s031lbl.pdf
06/02/2022	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020725s028lbl.pdf
06/02/2022	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020725s028lbl.pdf
03/20/2020	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020725s026lbl.pdf
03/14/2013	SUPPL-16	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020725s016lbl.pdf
07/12/2011	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s008lbl.pdf
06/10/2011	SUPPL-11	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf
05/09/2011	SUPPL-14	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf
08/12/2010	SUPPL-7	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s007lbl.pdf
07/29/2010	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s006lbl.pdf
04/30/2010	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s003lbl.pdf
04/30/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020725s000lbl.pdf

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