Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 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 No No
CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 60,000USP UNITS;12,000USP UNITS;38,000USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 120,000USP UNITS;24,000USP UNITS;76,000USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 15,000USP UNITS;3,000USP UNITS;9,500USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
CREON PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 180,000USP UNITS;36,000USP UNITS;114,000USP 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
04/30/2009 ORIG-1 Approval N/A

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/20/2020 SUPPL-26 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020725s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020725Orig1s026ltr.pdf
05/09/2019 SUPPL-25 Supplement

Label is not available on this site.

06/16/2016 SUPPL-23 Supplement

Label is not available on this site.

04/10/2015 SUPPL-22 Supplement

Label is not available on this site.

01/05/2015 SUPPL-21 Supplement

Label is not available on this site.

11/19/2014 SUPPL-20 Supplement

Label is not available on this site.

11/21/2014 SUPPL-18 Supplement

Label is not available on this site.

02/28/2013 SUPPL-17 Supplement

Label is not available on this site.

03/14/2013 SUPPL-16 Supplement

Label is not available on this site.

11/20/2012 SUPPL-15 Supplement

Label is not available on this site.

05/09/2011 SUPPL-14 Supplement

Label is not available on this site.

06/10/2011 SUPPL-11 Supplement

Label is not available on this site.

03/17/2014 SUPPL-9 Supplement

Label is not available on this site.

07/12/2011 SUPPL-8 Supplement

Label is not available on this site.

08/12/2010 SUPPL-7 Supplement

Label is not available on this site.

07/29/2010 SUPPL-6 Supplement

Label is not available on this site.

04/30/2010 SUPPL-3 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-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020725s026lbl.pdf

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