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FDA BLA · BLA103411

ONCASPAR

pegaspargase

Sponsor: SIGMA TAU

APPLICATION
BLA103411
TYPE
BLA
ORIGINAL APPROVAL
1994-02-01
LATEST ACTION
2024-03-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

ONCASPARPrescription
PEGASPARGASE 750IU/VIAL · VIAL

Approval history

2024-03-13Labeling · Supplement 5207 · standard — Letter ↗AP
2022-12-22Labeling · Supplement 5205 · standard — Letter ↗AP
2021-11-02Labeling · Supplement 5201 · standard — Letter ↗AP
2020-06-17Labeling · Supplement 5198 · standard — Letter ↗AP
2019-01-03Efficacy · Supplement 5196 · standard — Label ↗AP
2016-10-07Labeling · Supplement 5188 · standard — Letter ↗AP
2014-04-22Labeling · Supplement 5180 · standard — Letter ↗AP
2011-03-23Supplement · Supplement 5126 — Label ↗AP
2006-07-24Efficacy · Supplement 5052 · standard — Label ↗AP
1994-02-01Type 3 - New Dosage Form · Original · unknownAP
VIEW ON DRUGS@FDA ↗

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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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