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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022210
Company: EURAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZENPEP PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 24,000USP UNITS;5,000USP UNITS;17,000USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
ZENPEP PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 42,000USP UNITS;10,000USP UNITS;32,000USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
ZENPEP PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 63,000USP UNITS;15,000USP UNITS;47,000USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
ZENPEP PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 84,000USP UNITS;20,000USP UNITS;63,000USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
ZENPEP PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 14,000USP UNITS;3,000USP UNITS;10,000USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
ZENPEP PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 105,000USP UNITS;25,000USP UNITS;79,000USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None No No
ZENPEP PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 168,000USP UNITS;40,000USP UNITS;126,000USP 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
08/27/2009 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022210s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022210s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022210_zenpep_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022210s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/28/2022 SUPPL-24 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022210Orig1s024ltr.pdf
03/20/2020 SUPPL-21 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022210s021lbl.pdf
12/19/2016 SUPPL-17 Supplement

Label is not available on this site.

03/25/2014 SUPPL-16 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022210s016lbl.pdf
12/09/2013 SUPPL-15 Supplement

Label is not available on this site.

04/11/2013 SUPPL-12 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022210Orig1s009,s012ltr.pdf
09/26/2014 SUPPL-11 Supplement

Label is not available on this site.

04/11/2013 SUPPL-9 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022210Orig1s009,s012ltr.pdf
06/10/2011 SUPPL-8 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022210s008ltr.pdf
06/15/2011 SUPPL-6 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022210s006ltr.pdf
07/13/2011 SUPPL-5 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s005lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/28/2022 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210s024lbl.pdf
09/28/2022 SUPPL-24 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210s024lbl.pdf
09/28/2022 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210s024lbl.pdf
03/20/2020 SUPPL-21 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022210s021lbl.pdf
03/20/2020 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022210s021lbl.pdf
03/25/2014 SUPPL-16 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022210s016lbl.pdf
04/11/2013 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf
04/11/2013 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf
04/11/2013 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf
07/13/2011 SUPPL-5 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s005lbl.pdf
06/15/2011 SUPPL-6 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s006lbl.pdf
08/27/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022210s000lbl.pdf
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