Creon Purple Book BLA 020725
- BLA number
- 020725
- Proprietary names
- Creon
- Proper names
- pancrelipase
- Applicant
- AbbVie Inc.
- 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 | Creon | pancrelipase | 351(a) | 6,000USP UNITS; 19,000USP UNITS; 30,000USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2009-04-30 | |
| 002 | Creon | pancrelipase | 351(a) | 12,000USP UNITS; 38,000USP UNITS; 60,000USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2009-04-30 | |
| 003 | Creon | pancrelipase | 351(a) | 24,000USP UNITS; 76,000USP UNITS; 120,000USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2009-04-30 | |
| 004 | Creon | pancrelipase | 351(a) | 3,000USP UNITS; 9,500USP UNITS; 15,000USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2011-06-10 | |
| 005 | Creon | pancrelipase | 351(a) | 36,000USP UNITS; 114,000USP UNITS; 180,000USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2013-03-14 | |
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 |
|---|
| 2021-06-01 | U | 001 | Creon | 351(a) | Rx | AbbVie Inc. |
| 2021-06-01 | U | 002 | Creon | 351(a) | Rx | AbbVie Inc. |
| 2021-06-01 | U | 003 | Creon | 351(a) | Rx | AbbVie Inc. |
| 2021-06-01 | U | 004 | Creon | 351(a) | Rx | AbbVie Inc. |
| 2021-06-01 | U | 005 | Creon | 351(a) | Rx | AbbVie Inc. |
| 2020-10-01 | U | 004 | Creon | 351(a) | Rx | AbbVie Inc. |
| 2020-05-01 | R | 001 | Creon | 351(a) | Rx | AbbVie Inc. |
| 2020-05-01 | R | 002 | Creon | 351(a) | Rx | AbbVie Inc. |
| 2020-05-01 | R | 003 | Creon | 351(a) | Rx | AbbVie Inc. |
| 2020-05-01 | R | 004 | Creon | 351(a) | Rx | AbbVie Inc. |
| 2020-05-01 | R | 005 | Creon | 351(a) | Rx | AbbVie Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-10-01 | 004 | Creon | 351(a) | Rx | Licensed | 2011-06-10 |
| 2020-05-01 | 001 | Creon | 351(a) | Rx | Licensed | 2009-04-30 |
| 2020-05-01 | 002 | Creon | 351(a) | Rx | Licensed | 2009-04-30 |
| 2020-05-01 | 003 | Creon | 351(a) | Rx | Licensed | 2009-04-30 |
| 2020-05-01 | 004 | Creon | 351(a) | Rx | Licensed | 2011-07-12 |
| 2020-05-01 | 005 | Creon | 351(a) | Rx | Licensed | 2013-03-14 |