FULPHILA (PEGFILGRASTIM-JMDB)
Summary
FDA approved FULPHILA (PEGFILGRASTIM-JMDB) by MYLAN GMBH. BLA (Biologic) approval (Labeling) on 2023-10-13. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
BLA761075-25
Action Date
2023-10-13
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
FULPHILA (generic: PEGFILGRASTIM-JMDB), INJECTABLE, INJECTION. Application: BLA761075
Company
Context & Analysis
MYLAN GMBH has 2 FDA actions in our database.
Frequently Asked Questions
How often does MYLAN GMBH have FDA actions?
MYLAN GMBH has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "BLA761075-25" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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