Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022542
Company: VIOKACE

• Medication Guide

• Summary Review

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

Products on BLA 22542

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIOKACE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	39,150USP UNITS;10,440USP UNITS;39,150USP UNITS	TABLET;ORAL	Prescription	None	No	No
VIOKACE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	78,300USP UNITS;20,880USP UNITS;78,300USP UNITS	TABLET;ORAL	Prescription	None	No	No

Labels for BLA 022542

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2024	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022542s009lbl.pdf
02/28/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022542s009lbl.pdf
09/28/2022	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022542Orig1s007CorrectedLbl.pdf
09/28/2022	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022542Orig1s007CorrectedLbl.pdf
09/28/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022542Orig1s007CorrectedLbl.pdf
03/20/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022542s005lbl.pdf
03/20/2020	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022542s005lbl.pdf
03/01/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022542s000lbl.pdf