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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 022542

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 022542

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/01/2012	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022542s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022542s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022542_viokace_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022542Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/20/2023	SUPPL-10	Supplement	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drusgsatfda_docs/nda/2024/022542Orig1s010.pdf
02/28/2024	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022542s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022542Orig1s009ltr.pdf
10/21/2022	SUPPL-8	Supplement	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/022542Orig1s008.pdf
09/28/2022	SUPPL-7	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022542Orig1s007CorrectedLbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022542Orig1s007CorrectedLtr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/022542Orig1s007.pdf
07/29/2014	SUPPL-6	Supplement	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/022542Orig1s006.pdf
03/20/2020	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022542s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022542Orig1s005ltr.pdf
07/29/2014	SUPPL-2	Supplement		Label is not available on this site.
01/06/2014	SUPPL-1	Supplement		Label is not available on this site.

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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022542s009lbl.pdf
02/28/2024	SUPPL-9	Labeling-Medication Guide	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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022542s005lbl.pdf
03/20/2020	SUPPL-5	Labeling-Package Insert	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

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