Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 Yes No
PANCREAZE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes No
PANCREAZE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes Yes
PANCREAZE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes No
PANCREAZE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 10,850USP UNITS;2,600USP UNITS;6,200USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes 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 Type 7 - Drug Already Marketed without Approved NDA STANDARD 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
08/04/2016 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/30/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/03/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/16/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/23/2014 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/27/2014 SUPPL-5 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s005lbl.pdf
03/07/2014 SUPPL-4 Manufacturing (CMC) 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 Manufacturing (CMC)

Label is not available on this site.

06/20/2011 SUPPL-2 REMS-Modified 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
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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