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FDA BLA · BLA761102

ASPARLAS

calaspargase pegol

Sponsor: SERVIER PHARMA LLC

APPLICATION
BLA761102
TYPE
BLA
ORIGINAL APPROVAL
2018-12-20
LATEST ACTION
2023-11-29
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ASPARLASPrescription
CALASPARGASE PEGOL-MKNL 3750UNITS/5ML · INJECTABLE · INTRAVENOUS

Approval history

2023-11-29Labeling · Supplement 13 · standard — Letter ↗AP
2021-12-21Labeling · Supplement 8 · standard — Letter ↗AP
2020-06-24Labeling · Supplement 3 · standard — Label ↗AP
2019-09-05Labeling · Supplement 2 · standard — Label ↗AP
2018-12-20Type 1 - New Molecular Entity · 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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