← FDA DRUG APPROVALS

FDA BLA · BLA101063

ELSPAR

Sponsor: MERCK

APPLICATION
BLA101063
TYPE
BLA
ORIGINAL APPROVAL
1978-01-10
LATEST ACTION
2013-07-16
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

ELSPARPrescription
ASPARAGINASE 10,000IU/VIAL · VIAL

Approval history

2013-07-16Labeling · Supplement 5169 · standard — Label ↗AP
2010-05-20Labeling · Supplement 5121 · standardAP
2007-03-30Labeling · Supplement 5081 · standard — Label ↗AP
2006-07-21Labeling · Supplement 5071 · standard — Letter ↗AP
2004-06-29Labeling · Supplement 5036 · standard — Letter ↗AP
2002-08-01Labeling · Supplement 5012 · standard — Letter ↗AP
1978-01-10Type 1 - New Molecular Entity · Original · unknownAP
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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