Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022542
Company: VIOKACE

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

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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
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

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