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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022523
Company: VIVUS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PANCREAZE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 24,600USP UNITS; 4,200USP UNITS; 14,200USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
PANCREAZE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
PANCREAZE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
PANCREAZE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
PANCREAZE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 149,900USP UNITS; 37,000USP UNITS; 97,300USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
PANCREAZE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 15,200USP UNITS; 2,600USP UNITS; 8,800USP UNITS CAPSULE, DELAYED RELEASE;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
04/12/2010 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022523lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022523s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022523_pancreaze_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022523Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/2021 SUPPL-16 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022523Orig1s016Corrected_ltr.pdf
01/28/2020 SUPPL-14 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s014lbl.pdf
03/20/2020 SUPPL-13 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022523Orig1s013ltr.pdf
08/04/2016 SUPPL-10 Supplement

Label is not available on this site.

03/30/2015 SUPPL-9 Supplement

Label is not available on this site.

03/03/2015 SUPPL-8 Supplement

Label is not available on this site.

05/16/2016 SUPPL-7 Supplement

Label is not available on this site.

06/23/2014 SUPPL-6 Supplement

Label is not available on this site.

05/27/2014 SUPPL-5 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s005lbl.pdf
03/07/2014 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022523Orig1s004ltr.pdf
12/07/2012 SUPPL-3 Supplement

Label is not available on this site.

06/20/2011 SUPPL-2 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022523s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/26/2021 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s016lbl.pdf
03/20/2020 SUPPL-13 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf
03/20/2020 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf
01/28/2020 SUPPL-14 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s014lbl.pdf
05/27/2014 SUPPL-5 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s005lbl.pdf
03/07/2014 SUPPL-4 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s004lbl.pdf
04/12/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022523lbl.pdf
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