# CREON — FDA application BLA020725

Informational only - not investment advice.

Application BLA020725 · type BLA · FDA status: approved · original approval 2009-04-30

Listed sponsor: ABBVIE · [ABBV company profile](/company/ABBV/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE | ORAL | 30,000USP UNITS;6,000USP UNITS;19,000USP UNITS | Prescription | not listed | not listed |
| 002 | CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE | ORAL | 60,000USP UNITS;12,000USP UNITS;38,000USP UNITS | Prescription | not listed | not listed |
| 003 | CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE | ORAL | 120,000USP UNITS;24,000USP UNITS;76,000USP UNITS | Prescription | not listed | not listed |
| 004 | CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE | ORAL | 15,000USP UNITS;3,000USP UNITS;9,500USP UNITS | Prescription | not listed | not listed |
| 005 | CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE | ORAL | 180,000USP UNITS;36,000USP UNITS;114,000USP UNITS | Prescription | not listed | not listed |

## Orange Book patent and exclusivity listings

Patent/exclusivity listings: not applicable — the FDA Orange Book covers NDA and ANDA small-molecule applications, not BLA biologics.

## Compound cross-links

- PANCRELIPASE AMYLASE · UNII YOJ58O116E · no lmmol compound match
- PANCRELIPASE LIPASE · UNII 8MYC33932O · no lmmol compound match
- PANCRELIPASE PROTEASE · UNII 3560D81V50 · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/ABBV/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA020725. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.