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FDA BLA · BLA125288

NULOJIX

belatacept

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
BLA125288
TYPE
BLA
ORIGINAL APPROVAL
2011-06-15
LATEST ACTION
2021-07-28
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NULOJIXPrescription
BELATACEPT 250MG · INJECTABLE · INJECTION

Approval history

2021-07-28Labeling · Supplement 101 · standard — Letter ↗AP
2018-04-13Efficacy · Supplement 75 · standard — Label ↗AP
2017-11-09Labeling · Supplement 74 · standard — Letter ↗AP
2017-05-09REMS · Supplement 72 — Letter ↗AP
2017-02-02Labeling · Supplement 70 · standard — Letter ↗AP
2014-09-30Labeling · Supplement 62 · standard — Letter ↗AP
2014-04-15Labeling · Supplement 59 · standard — Label ↗AP
2013-04-08Labeling · Supplement 30 · standard — Letter ↗AP
2011-06-15Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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