CREON — FDA application BLA020725
Listed sponsor: ABBVIE · ABBV company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
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 · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.