Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 022523
Company: VIVUS INC
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 | No | No |
PANCREAZE | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS | CAPSULE, DELAYED RELEASE;ORAL | Prescription | None | No | No |
PANCREAZE | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS | CAPSULE, DELAYED RELEASE;ORAL | Prescription | None | No | No |
PANCREAZE | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS | CAPSULE, DELAYED RELEASE;ORAL | Prescription | None | No | No |
PANCREAZE | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 149,900USP UNITS; 37,000USP UNITS; 97,300USP UNITS | CAPSULE, DELAYED RELEASE;ORAL | Prescription | None | No | No |
PANCREAZE | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 15,200USP UNITS; 2,600USP UNITS; 8,800USP 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 |
---|---|---|---|---|---|---|---|
04/12/2010 | ORIG-1 | Approval | N/A |
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 |
---|---|---|---|---|---|
02/28/2024 | SUPPL-19 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022523s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022523Orig1s019ltr.pdf | |
04/26/2021 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022523Orig1s016Corrected_ltr.pdf | |
01/28/2020 | SUPPL-14 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s014lbl.pdf | |
03/20/2020 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022523Orig1s013ltr.pdf | |
08/04/2016 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
03/30/2015 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
03/03/2015 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
05/16/2016 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
06/23/2014 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
05/27/2014 | SUPPL-5 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s005lbl.pdf | |
03/07/2014 | SUPPL-4 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
06/20/2011 | SUPPL-2 | Supplement |
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 |
---|---|---|---|---|---|
02/28/2024 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022523s019lbl.pdf | |
04/26/2021 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s016lbl.pdf | |
03/20/2020 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf | |
03/20/2020 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf | |
01/28/2020 | SUPPL-14 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s014lbl.pdf |
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 |