← FDA DRUG APPROVALS

FDA BLA · BLA125294

GRANIX

tbo-filgrastim

Sponsor: SICOR BIOTECH

APPLICATION
BLA125294
TYPE
BLA
ORIGINAL APPROVAL
2012-08-29
LATEST ACTION
2023-11-21
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

GRANIXPrescription
TBO-FILGRASTIM 300MCG/0.5ML · INJECTABLE · INJECTION
GRANIXPrescription
TBO-FILGRASTIM 480MCG/0.8ML · INJECTABLE · INJECTION

Approval history

2023-11-21Labeling · Supplement 58 · standard — Label ↗AP
2019-10-09Labeling · Supplement 48 · standard — Letter ↗AP
2019-03-28Labeling · Supplement 46 · standard — Letter ↗AP
2018-07-31Efficacy · Supplement 45 · priority — Label ↗AP
2017-06-21Labeling · Supplement 42 · standard — Letter ↗AP
2017-02-02Labeling · Supplement 40 · standard — Letter ↗AP
2014-12-19Labeling · Supplement 35 · standard — Label ↗AP
2013-07-19Labeling · Supplement 7 · standard — Label ↗AP
2012-08-29Type 1 - New Molecular Entity · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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