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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022175
Company: DIGESTIVE CARE INC

Medication Guide

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

Products on BLA 022175

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERTZYE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	30,250USP UNITS;8,000USP UNITS;28,750USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
PERTZYE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	60,500USP UNITS;16,000USP UNITS;57,500USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
PERTZYE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	15,125USP UNITS;4,000USP UNITS;14,375USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
PERTZYE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	90,750USP UNITS;24,000USP UNITS;86,250USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 022175

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/2012	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022175s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022175s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022175Orig1s000SumR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022175_pertzye_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2022	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022175s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022175Orig1s008ltr.pdf
03/20/2020	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022175s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022175Orig1s006ltr.pdf
07/12/2017	SUPPL-4	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022175s004lbl.pdf
10/06/2016	SUPPL-3	Supplement		Label is not available on this site.
01/23/2014	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 022175

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2022	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022175s008lbl.pdf
09/28/2022	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022175s008lbl.pdf
09/28/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022175s008lbl.pdf
03/20/2020	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022175s006lbl.pdf
03/20/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022175s006lbl.pdf
07/12/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022175s004lbl.pdf
05/17/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022175s000lbl.pdf

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