# ARANESP — FDA application BLA103951

Informational only - not investment advice.

Application BLA103951 · type BLA · FDA status: approved · original approval 2001-09-17

Listed sponsor: AMGEN · [AMGN company profile](/company/AMGN/) · 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 | ARANESP | DARBEPOETIN ALFA | VIAL | INTRAVENOUS | 25UG/ML | Prescription | not listed | not listed |
| 002 | ARANESP | DARBEPOETIN ALFA | VIAL | INTRAVENOUS | 40UG/ML | Prescription | not listed | not listed |
| 003 | ARANESP | DARBEPOETIN ALFA | VIAL | INTRAVENOUS | 60UG/ML | Prescription | not listed | not listed |
| 004 | ARANESP | DARBEPOETIN ALFA | VIAL | INTRAVENOUS | 100UG/ML | Prescription | not listed | not listed |
| 005 | ARANESP | DARBEPOETIN ALFA | VIAL | INTRAVENOUS | 200UG/ML | Prescription | not listed | not listed |
| 006 | ARANESP | DARBEPOETIN ALFA | VIAL | SUBCUTANEOUS | 25UG/ML | Prescription | not listed | not listed |
| 007 | ARANESP | DARBEPOETIN ALFA | VIAL | SUBCUTANEOUS | 40UG/ML | Prescription | not listed | not listed |
| 008 | ARANESP | DARBEPOETIN ALFA | VIAL | SUBCUTANEOUS | 60UG/ML | Prescription | not listed | not listed |
| 009 | ARANESP | DARBEPOETIN ALFA | VIAL | SUBCUTANEOUS | 100UG/ML | Prescription | not listed | not listed |
| 010 | ARANESP | DARBEPOETIN ALFA | VIAL | SUBCUTANEOUS | 200UG/ML | 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

- DARBEPOETIN ALFA · UNII 15UQ94PT4P · 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/AMGN/)
- [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:BLA103951. FDA data retrieved 2026-08-07.

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