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FDA BLA · BLA761080

NIVESTYM

filgrastim-aafi

Sponsor: HOSPIRA INC

APPLICATION
BLA761080
TYPE
BLA
ORIGINAL APPROVAL
2018-07-20
LATEST ACTION
2024-02-16
ROUTE
SUBCUTANEOUS, INTRAVENOUS, INJECTION, SINGLE-DOSE
DOSAGE FORM
INJECTABLE, VIAL
MARKETING STATUS
Prescription

Products

NIVESTYMPrescription
FILGRASTIM-AAFI 480MCG/0.8ML · INJECTABLE · INJECTION
NIVESTYMPrescription
FILGRASTIM-AAFI 480MCG/1.6ML · VIAL · SINGLE-DOSE
NIVESTYMPrescription
FILGRASTIM-AAFI 300MCG/0.5ML · INJECTABLE · INJECTION
NIVESTYMPrescription
FILGRASTIM-AAFI 300MCG/ML · VIAL · SINGLE-DOSE

Approval history

2024-02-16Labeling · Supplement 14 · standard — Letter ↗AP
2023-08-28Labeling · Supplement 11 · standard — Label ↗AP
2021-05-03Labeling · Supplement 7 · standard — Letter ↗AP
2018-07-20Type 2 - New Active Ingredient · Original · standard — Label ↗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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