← FDA DRUG APPROVALS

FDA BLA · BLA761075

FULPHILA

pegfilgrastim-jmdb

Sponsor: MYLAN GMBH

APPLICATION
BLA761075
TYPE
BLA
ORIGINAL APPROVAL
2018-06-04
LATEST ACTION
2023-10-13
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FULPHILAPrescription
PEGFILGRASTIM-JMDB 6MG/0.6ML · INJECTABLE · INJECTION

Approval history

2023-10-13Labeling · Supplement 25 · standard — Letter ↗AP
2021-03-17Labeling · Supplement 12 · standard — Letter ↗AP
2019-05-29Labeling · Supplement 4 · standard — Label ↗AP
2019-03-21Labeling · Supplement 1 · standard — Label ↗AP
2018-06-04Type 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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