FDA BLA · BLA103764

SIMULECT

basiliximab

Sponsor: NOVARTIS

APPLICATION

BLA103764

TYPE

BLA

ORIGINAL APPROVAL

1998-05-12

LATEST ACTION

2005-09-15

ROUTE

INTRAVENOUS, SINGLE-USE

DOSAGE FORM

VIAL

MARKETING STATUS

Prescription

Products

SIMULECTPrescription

BASILIXIMAB 20MG · VIAL · SINGLE-USE

SIMULECTPrescription

BASILIXIMAB 10MG · VIAL · SINGLE-USE

2005-09-15Labeling · Supplement 5059 · standardAP

2003-11-14Labeling · Supplement 5040 · standard — Letter ↗AP

2003-05-27Labeling · Supplement 5046 · standardAP

2003-01-02Supplement · Supplement 5037 — Label ↗AP

2001-11-29Labeling · Supplement 5006 · standardAP

2001-03-23Efficacy · Supplement 5003 · standard — Label ↗AP

2001-03-22Efficacy · Supplement 1010 · standardAP

1998-05-12Type 1 - New Molecular Entity · Original · priority — Review ↗AP

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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