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FDA BLA · BLA761039

UDENYCA

pegfilgrastim-cbqv

Sponsor: COHERUS BIOSCIENCES INC

APPLICATION
BLA761039
TYPE
BLA
ORIGINAL APPROVAL
2018-11-02
LATEST ACTION
2023-12-22
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

UDENYCAPrescription
PEGFILGRASTIM-CBQV 6MG/0.6ML · INJECTABLE · INJECTION

Approval history

2023-12-22Efficacy · Supplement 15 · standard — Label ↗AP
2023-03-03Efficacy · Supplement 13 · standard — Label ↗AP
2022-11-28Efficacy · Supplement 14 · standard — Letter ↗AP
2021-06-07Labeling · Supplement 10 · standard — Letter ↗AP
2020-02-12Labeling · Supplement 3 · standard — Label ↗AP
2019-10-17Labeling · Supplement 4 · standard — Letter ↗AP
2019-04-16Labeling · Supplement 1 · standard — Letter ↗AP
2018-11-02Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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