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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022210
Company: EURAND PHARMA LTD

Medication Guide

Summary Review

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

Products on BLA 022210

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	24,000USP UNITS;5,000USP UNITS;17,000USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	42,000USP UNITS;10,000USP UNITS;32,000USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	63,000USP UNITS;15,000USP UNITS;47,000USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	84,000USP UNITS;20,000USP UNITS;63,000USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	14,000USP UNITS;3,000USP UNITS;10,000USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	105,000USP UNITS;25,000USP UNITS;79,000USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	168,000USP UNITS;40,000USP UNITS;126,000USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 022210

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/27/2009	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022210s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022210s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022210_zenpep_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022210s000sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/27/2023	SUPPL-27	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022210Orig1s027ltr.pdf
02/28/2024	SUPPL-26	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022210s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022210Orig1s026ltr.pdf
09/28/2022	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210Orig1s024_CorrectedLbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022210Orig1s024CorrectedLtr.pdf
03/20/2020	SUPPL-21	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022210s021lbl.pdf
12/19/2016	SUPPL-17	Supplement		Label is not available on this site.
03/25/2014	SUPPL-16	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022210s016lbl.pdf
12/09/2013	SUPPL-15	Supplement		Label is not available on this site.
04/11/2013	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022210Orig1s009,s012ltr.pdf
09/26/2014	SUPPL-11	Supplement		Label is not available on this site.
04/11/2013	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022210Orig1s009,s012ltr.pdf
06/10/2011	SUPPL-8	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022210s008ltr.pdf
06/15/2011	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022210s006ltr.pdf
07/13/2011	SUPPL-5	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s005lbl.pdf

Labels for BLA 022210

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2024	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022210s026lbl.pdf
09/28/2022	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210Orig1s024_CorrectedLbl.pdf
09/28/2022	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210Orig1s024_CorrectedLbl.pdf
09/28/2022	SUPPL-24	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210Orig1s024_CorrectedLbl.pdf
03/20/2020	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022210s021lbl.pdf
03/20/2020	SUPPL-21	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022210s021lbl.pdf
03/25/2014	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022210s016lbl.pdf
04/11/2013	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf
04/11/2013	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf
04/11/2013	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf
07/13/2011	SUPPL-5	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s005lbl.pdf
06/15/2011	SUPPL-6	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s006lbl.pdf
08/27/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022210s000lbl.pdf

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