Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 022210
Company: EURAND PHARMA LTD
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 |
---|---|---|---|---|---|
10/27/2023 | SUPPL-27 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022210Orig1s027ltr.pdf |
02/28/2024 | SUPPL-26 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022210s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022210Orig1s026ltr.pdf | |
09/28/2022 | SUPPL-24 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210Orig1s024_CorrectedLbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022210Orig1s024CorrectedLtr.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 |
---|---|---|---|---|---|
02/28/2024 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022210s026lbl.pdf | |
09/28/2022 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210Orig1s024_CorrectedLbl.pdf | |
09/28/2022 | SUPPL-24 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210Orig1s024_CorrectedLbl.pdf | |
09/28/2022 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210Orig1s024_CorrectedLbl.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 |