← FDA DRUG APPROVALS

FDA BLA · BLA761045

ZIEXTENZO

pegfilgrastim-bmez

Sponsor: SANDOZ INC

APPLICATION
BLA761045
TYPE
BLA
ORIGINAL APPROVAL
2019-11-04
LATEST ACTION
2026-05-12
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZIEXTENZOPrescription
PEGFILGRASTIM-BMEZ 6MG/0.6ML · INJECTABLE · INJECTION

Approval history

2026-05-12Labeling · Supplement 17 · standard — Letter ↗AP
2024-02-28BIOSIMILAR · Supplement 14 — Label ↗AP
2023-10-09Manufacturing (CMC) · Supplement 11 — Letter ↗AP
2021-03-12Labeling · Supplement 6 · standard — Label ↗AP
2019-11-04Type 5 - New Formulation or New Manufacturer · 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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