Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020725
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 30,000USP UNITS;6,000USP UNITS;19,000USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes No
CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 60,000USP UNITS;12,000USP UNITS;38,000USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes No
CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 120,000USP UNITS;24,000USP UNITS;76,000USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes Yes
CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 15,000USP UNITS;3,000USP UNITS;9,500USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes No
CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 180,000USP UNITS;36,000USP UNITS;114,000USP 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
04/30/2009 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020725s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020725s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020725_creon_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020725s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2019 SUPPL-25 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020725Orig1s025ltr.pdf
06/16/2016 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/10/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/19/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/21/2014 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/28/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/14/2013 SUPPL-16 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020725s016lbl.pdf
11/20/2012 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/09/2011 SUPPL-14 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020725s014ltr.pdf
06/10/2011 SUPPL-11 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020725s011ltr.pdf
03/17/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/12/2011 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020725s008ltr.pdf
08/12/2010 SUPPL-7 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020725s007ltr.pdf
07/29/2010 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020725s006ltr.pdf
04/30/2010 SUPPL-3 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020725s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/14/2013 SUPPL-16 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020725s016lbl.pdf
07/12/2011 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s008lbl.pdf
06/10/2011 SUPPL-11 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf
05/09/2011 SUPPL-14 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf
08/12/2010 SUPPL-7 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s007lbl.pdf
07/29/2010 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s006lbl.pdf
04/30/2010 SUPPL-3 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s003lbl.pdf
04/30/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020725s000lbl.pdf

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