An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
02/28/2024	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022175s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022175Orig1s010ltr.pdf
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
02/28/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022175s010lbl.pdf
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

Top