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 22210

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
ZENPEP	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	252,600USP UNITS;60,000USP UNITS;189,600USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No

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-Medication Guide	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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210Orig1s024_CorrectedLbl.pdf
03/20/2020	SUPPL-21	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022210s021lbl.pdf
03/20/2020	SUPPL-21	Labeling-Package Insert	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