# NEUPOGEN — FDA application BLA103353

Informational only - not investment advice.

Application BLA103353 · type BLA · FDA status: approved · original approval 1991-02-20

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 | NEUPOGEN | FILGRASTIM | VIAL | not listed | 300MCG/1ML | Prescription | not listed | not listed |
| 002 | NEUPOGEN | FILGRASTIM | VIAL | not listed | 480MCG/1.6ML | Prescription | not listed | not listed |
| 003 | NEUPOGEN | FILGRASTIM | SYRINGE | not listed | 300MGC/0.5ML | Prescription | not listed | not listed |
| 004 | NEUPOGEN | FILGRASTIM | SYRINGE | not listed | 480MCG/0.8ML | 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

- FILGRASTIM · UNII PVI5M0M1GW · 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:BLA103353. FDA data retrieved 2026-08-07.

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