NEUPOGEN — FDA application BLA103353
Listed sponsor: AMGEN · AMGN 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 | NEUPOGEN | FILGRASTIM | VIAL | 300MCG/1ML | Prescription | not listed | not listed | |
| 002 | NEUPOGEN | FILGRASTIM | VIAL | 480MCG/1.6ML | Prescription | not listed | not listed | |
| 003 | NEUPOGEN | FILGRASTIM | SYRINGE | 300MGC/0.5ML | Prescription | not listed | not listed | |
| 004 | NEUPOGEN | FILGRASTIM | SYRINGE | 480MCG/0.8ML | 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
- 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 · 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.