Pancreaze Purple Book BLA 022523
- BLA number
- 022523
- Proprietary names
- Pancreaze
- Proper names
- pancrelipase
- Applicant
- VIVUS LLC
- Center
- CDER
- First observed release
- 2020-05-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Pancreaze | pancrelipase | 351(a) | 4,200USP UNITS; 14,200USP UNITS; 24,600USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2010-04-12 | |
| 002 | Pancreaze | pancrelipase | 351(a) | 10,500USP UNITS; 35,500USP UNITS; 61,500USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2010-04-12 | |
| 003 | Pancreaze | pancrelipase | 351(a) | 16,800USP UNITS; 56,800USP UNITS; 98,400USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2010-04-12 | |
| 004 | Pancreaze | pancrelipase | 351(a) | 21,000USP UNITS; 54,700USP UNITS; 83,900USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2010-04-12 | |
| 005 | Pancreaze | pancrelipase | 351(a) | 2,600USP UNITS; 8,800USP UNITS; 15,200USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2014-03-07 | |
| 006 | Pancreaze | pancrelipase | 351(a) | 37,000USP UNITS; 97,300USP UNITS; 149,900USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2021-04-26 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2022-05-01 | U | 001 | Pancreaze | 351(a) | Rx | VIVUS LLC |
| 2022-05-01 | U | 002 | Pancreaze | 351(a) | Rx | VIVUS LLC |
| 2022-05-01 | U | 003 | Pancreaze | 351(a) | Rx | VIVUS LLC |
| 2022-05-01 | U | 004 | Pancreaze | 351(a) | Rx | VIVUS LLC |
| 2022-05-01 | U | 005 | Pancreaze | 351(a) | Rx | VIVUS LLC |
| 2022-05-01 | U | 006 | Pancreaze | 351(a) | Rx | VIVUS LLC |
| 2021-06-01 | U | 001 | Pancreaze | 351(a) | Rx | VIVUS, Inc. |
| 2021-06-01 | U | 002 | Pancreaze | 351(a) | Rx | VIVUS, Inc. |
| 2021-06-01 | U | 003 | Pancreaze | 351(a) | Rx | VIVUS, Inc. |
| 2021-06-01 | U | 004 | Pancreaze | 351(a) | Rx | VIVUS, Inc. |
| 2021-06-01 | U | 005 | Pancreaze | 351(a) | Rx | VIVUS, Inc. |
| 2021-06-01 | U | 006 | Pancreaze | 351(a) | Rx | VIVUS, Inc. |
| 2020-05-01 | R | 001 | Pancreaze | 351(a) | Rx | VIVUS, Inc. |
| 2020-05-01 | R | 002 | Pancreaze | 351(a) | Rx | VIVUS, Inc. |
| 2020-05-01 | R | 003 | Pancreaze | 351(a) | Rx | VIVUS, Inc. |
| 2020-05-01 | R | 004 | Pancreaze | 351(a) | Rx | VIVUS, Inc. |
| 2020-05-01 | R | 005 | Pancreaze | 351(a) | Rx | VIVUS, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2021-06-01 | 006 | Pancreaze | 351(a) | Rx | Licensed | 2021-04-26 |
| 2020-05-01 | 001 | Pancreaze | 351(a) | Rx | Licensed | 2010-04-12 |
| 2020-05-01 | 002 | Pancreaze | 351(a) | Rx | Licensed | 2010-04-12 |
| 2020-05-01 | 003 | Pancreaze | 351(a) | Rx | Licensed | 2010-04-12 |
| 2020-05-01 | 004 | Pancreaze | 351(a) | Rx | Licensed | 2010-04-12 |
| 2020-05-01 | 005 | Pancreaze | 351(a) | Rx | Licensed | 2014-03-07 |