Zenpep Purple Book BLA 022210
- BLA number
- 022210
- Proprietary names
- Zenpep
- Proper names
- pancrelipase
- Applicant
- Zenpep, 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 | Zenpep | pancrelipase | 351(a) | 5,000USP UNITS; 17,000USP UNITS; 24,000USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2009-08-27 | |
| 002 | Zenpep | pancrelipase | 351(a) | 10,000USP UNITS; 32,000USP UNITS; 42,000USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2009-08-27 | |
| 003 | Zenpep | pancrelipase | 351(a) | 15,000USP UNITS; 47,000USP UNITS; 63,000USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2009-08-27 | |
| 004 | Zenpep | pancrelipase | 351(a) | 20,000USP UNITS; 63,000USP UNITS; 84,000USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2009-08-27 | |
| 005 | Zenpep | pancrelipase | 351(a) | 3,000USP UNITS; 10,000USP UNITS; 14,000USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2011-06-15 | |
| 006 | Zenpep | pancrelipase | 351(a) | 25,000USP UNITS; 79,000USP UNITS; 105,000USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2011-07-13 | |
| 007 | Zenpep | pancrelipase | 351(a) | 40,000USP UNITS; 126,000USP UNITS; 168,000USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2014-03-25 | |
| 008 | Zenpep | pancrelipase | 351(a) | 60,000USP UNITS; 189,600USP UNITS; 252,600USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2023-10-27 | |
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 |
|---|
| 2023-11-01 | N | 008 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2021-06-01 | U | 001 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2021-06-01 | U | 002 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2021-06-01 | U | 003 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2021-06-01 | U | 004 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2021-06-01 | U | 005 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2021-06-01 | U | 006 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2021-06-01 | U | 007 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-09-01 | U | 001 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-09-01 | U | 002 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-09-01 | U | 003 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-09-01 | U | 004 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-09-01 | U | 005 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-09-01 | U | 006 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-09-01 | U | 007 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-05-01 | R | 001 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-05-01 | R | 002 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-05-01 | R | 003 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-05-01 | R | 004 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-05-01 | R | 005 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-05-01 | R | 006 | Zenpep | 351(a) | Rx | Zenpep, LLC |
| 2020-05-01 | R | 007 | Zenpep | 351(a) | Rx | Zenpep, LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-11-01 | 008 | Zenpep | 351(a) | Rx | Licensed | 2023-10-27 |
| 2020-05-01 | 001 | Zenpep | 351(a) | Rx | Licensed | 2009-08-27 |
| 2020-05-01 | 002 | Zenpep | 351(a) | Rx | Licensed | 2009-08-27 |
| 2020-05-01 | 003 | Zenpep | 351(a) | Rx | Licensed | 2009-08-27 |
| 2020-05-01 | 004 | Zenpep | 351(a) | Rx | Licensed | 2009-08-27 |
| 2020-05-01 | 005 | Zenpep | 351(a) | Rx | Licensed | 2011-06-15 |
| 2020-05-01 | 006 | Zenpep | 351(a) | Rx | Licensed | 2011-07-13 |
| 2020-05-01 | 007 | Zenpep | 351(a) | Rx | Licensed | 2014-03-25 |