← FDA DRUG APPROVALS

FDA BLA · BLA103353

NEUPOGEN

filgrastim

Sponsor: AMGEN

APPLICATION
BLA103353
TYPE
BLA
ORIGINAL APPROVAL
1991-02-20
LATEST ACTION
2026-07-16
ROUTE
INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SYRINGE, VIAL
MARKETING STATUS
Prescription

Products

NEUPOGENPrescription
FILGRASTIM 300MGC/0.5ML · SYRINGE
NEUPOGENPrescription
FILGRASTIM 300MCG/1ML · VIAL
NEUPOGENPrescription
FILGRASTIM 480MCG/0.8ML · SYRINGE
NEUPOGENPrescription
FILGRASTIM 480MCG/1.6ML · VIAL

Approval history

2026-07-16Labeling · Supplement 5202 · standard — Letter ↗AP
2025-04-18Labeling · Supplement 5201 · standard — Label ↗AP
2023-04-18Labeling · Supplement 5198 · standard — Label ↗AP
2021-02-04Labeling · Supplement 5197 · standard — Letter ↗AP
2021-01-05Labeling · Supplement 5196 · standard — Letter ↗AP
2018-06-18Labeling · Supplement 5194 · standard — Letter ↗AP
2016-06-29Labeling · Supplement 5188 · standard — Label ↗AP
2015-07-30Labeling · Supplement 5186 · standard — Label ↗AP
2015-03-30Efficacy · Supplement 5183 · standard — Label ↗AP
2015-02-06Labeling · Supplement 5184 · standard — Letter ↗AP
2013-09-13Labeling · Supplement 5157 · standard — Letter ↗AP
2012-05-25Labeling · Supplement 5147 · standard — Label ↗AP
2010-03-02Labeling · Supplement 5127 · standard — Label ↗AP
2007-09-27Labeling · Supplement 5099 · standardAP
2006-10-25Supplement · Supplement 5086 — Label ↗AP
2004-12-17Labeling · Supplement 5059 · standard — Label ↗AP
2004-11-24Labeling · Supplement 5058 · standardAP
2002-05-29Labeling · Supplement 5001 · standard — Label ↗AP
2001-06-21Labeling · Supplement 1051 · standardAP
1998-04-02Efficacy · Supplement 1036 · unknown — Label ↗AP
1995-12-28Efficacy · Supplement 1027 · unknownAP
1994-12-19Efficacy · Supplement 1007 · priorityAP
1994-06-15Efficacy · Supplement 1009 · unknownAP
1991-02-20Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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