Pertzye Purple Book BLA 022175
- BLA number
- 022175
- Proprietary names
- Pertzye
- Proper names
- pancrelipase
- Applicant
- Digestive Care, 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 | Pertzye | pancrelipase | 351(a) | 8,000USP UNITS; 28,750USP UNITS; 30,250USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2012-05-17 | |
| 002 | Pertzye | pancrelipase | 351(a) | 16,000USP UNITS; 57,500USP UNITS; 60,500USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2012-05-17 | |
| 003 | Pertzye | pancrelipase | 351(a) | 4,000USP UNITS; 14,375USP UNITS; 15,125USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2016-10-06 | |
| 004 | Pertzye | pancrelipase | 351(a) | 24,000USP UNITS; 86,250USP UNITS; 90,750USP UNITS | Capsule, Delayed Release | Oral | | Rx | Licensed | 2017-07-13 | |
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 |
|---|
| 2022-10-01 | U | 001 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2022-10-01 | U | 002 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2022-10-01 | U | 003 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2022-10-01 | U | 004 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2021-06-01 | U | 001 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2021-06-01 | U | 002 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2021-06-01 | U | 003 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2021-06-01 | U | 004 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2021-04-01 | U | 001 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2021-04-01 | U | 002 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2021-04-01 | U | 003 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2020-09-01 | U | 001 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2020-09-01 | U | 002 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2020-09-01 | U | 003 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2020-09-01 | U | 004 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2020-05-01 | R | 001 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2020-05-01 | R | 002 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2020-05-01 | R | 003 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
| 2020-05-01 | R | 004 | Pertzye | 351(a) | Rx | Digestive Care, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Pertzye | 351(a) | Rx | Licensed | 2012-05-17 |
| 2020-05-01 | 002 | Pertzye | 351(a) | Rx | Licensed | 2012-05-17 |
| 2020-05-01 | 003 | Pertzye | 351(a) | Rx | Licensed | 2016-10-06 |
| 2020-05-01 | 004 | Pertzye | 351(a) | Rx | Licensed | 2017-07-13 |