← FDA DRUG APPROVALS

FDA BLA · BLA125031

NEULASTA

pegfilgrastim

Sponsor: AMGEN

APPLICATION
BLA125031
TYPE
BLA
ORIGINAL APPROVAL
2002-01-31
LATEST ACTION
2025-08-18
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SYRINGE
MARKETING STATUS
Prescription

Products

NEULASTAPrescription
PEGFILGRASTIM 6MG/0.6ML · SYRINGE

Approval history

2025-08-18Manufacturing (CMC) · Supplement 209 — Letter ↗AP
2021-02-02Labeling · Supplement 203 · standard — Letter ↗AP
2021-01-05Labeling · Supplement 202 · standard — Letter ↗AP
2020-11-18Labeling · Supplement 201 · standard — Label ↗AP
2020-01-06Labeling · Supplement 199 · standard — Label ↗AP
2019-04-16Labeling · Supplement 198 · standard — Letter ↗AP
2018-06-18Labeling · Supplement 193 · standard — Letter ↗AP
2017-12-09Labeling · Supplement 191 · standard — Label ↗AP
2017-12-09Labeling · Supplement 189 · standard — Label ↗AP
2016-04-28Labeling · Supplement 184 · standard — Label ↗AP
2015-11-13Efficacy · Supplement 180 · priority — Label ↗AP
2015-09-23Labeling · Supplement 179 · standard — Label ↗AP
2015-09-23Labeling · Supplement 181 · standard — Label ↗AP
2015-09-23Labeling · Supplement 170 · standard — Label ↗AP
2014-12-23Manufacturing (CMC) · Supplement 175 — Review ↗AP
2012-05-25Labeling · Supplement 142 · standard — Label ↗AP
2011-06-03Labeling · Supplement 130 · standard — Letter ↗AP
2010-02-17Labeling · Supplement 120 · standard — Letter ↗AP
2008-11-14Supplement · Supplement 91 — Letter ↗AP
2008-11-14Labeling · Supplement 105 · standard — Letter ↗AP
2008-04-16Labeling · Supplement 95 · standard — Letter ↗AP
2007-07-23Labeling · Supplement 82 · standard — Letter ↗AP
2006-10-25Supplement · Supplement 72 — Label ↗AP
2005-09-15Efficacy · Supplement 52 · standard — Label ↗AP
2005-01-24Labeling · Supplement 51 · standard — Label ↗AP
2004-12-17Labeling · Supplement 48 · standard — Label ↗AP
2004-11-24Labeling · Supplement 43 · standardAP
2004-11-03Labeling · Supplement 39 · standardAP
2002-01-31Type 1 - New Molecular Entity · Original · standard — Patient Package Insert ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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