← FDA DRUG APPROVALS

FDA NDA · NDA050573

SANDIMMUNE

cyclosporine

Sponsor: NOVARTIS

APPLICATION
NDA050573
TYPE
NDA
ORIGINAL APPROVAL
1983-11-14
LATEST ACTION
2026-03-06
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SANDIMMUNE · ReferencePrescription
CYCLOSPORINE 50MG/ML · INJECTABLE · INJECTION

Approval history

2026-03-06Labeling · Supplement 48 · standard — Letter ↗AP
2023-09-28Labeling · Supplement 44 · standard — Label ↗AP
2015-11-02Manufacturing (CMC) · Supplement 40 · priorityAP
2015-03-31Labeling · Supplement 41 · standard — Label ↗AP
2013-05-03Labeling · Supplement 39 · standard — Label ↗AP
2013-02-07Manufacturing (CMC) · Supplement 38 · priorityAP
2012-08-30Labeling · Supplement 35 · standard — Letter ↗AP
2010-04-30Labeling · Supplement 34 · unknown — Letter ↗AP
2009-10-08Labeling · Supplement 33 · unknown — Letter ↗AP
2006-03-06Labeling · Supplement 31 · standard — Letter ↗AP
2005-07-19Labeling · Supplement 30 · standard — Letter ↗AP
2004-02-06Labeling · Supplement 28 · standard — Label ↗AP
2004-02-06Labeling · Supplement 27 · standard — Letter ↗AP
2003-02-14Labeling · Supplement 23 · standard — Label ↗AP
2003-02-14Labeling · Supplement 21 · standard — Letter ↗AP
2002-04-12Manufacturing (CMC) · Supplement 25 · priorityAP
2002-01-16Manufacturing (CMC) · Supplement 24 · priorityAP
2001-04-04Manufacturing (CMC) · Supplement 19 · priorityAP
2001-03-09Manufacturing (CMC) · Supplement 20 · priorityAP
2000-10-04Labeling · Supplement 18 · standardAP
1999-12-21Labeling · Supplement 17 · standardAP
1999-05-13Manufacturing (CMC) · Supplement 16 · priorityAP
1998-10-20Manufacturing (CMC) · Supplement 15 · priorityAP
1998-03-30Manufacturing (CMC) · Supplement 14 · priorityAP
1996-08-09Labeling · Supplement 12 · standardAP
1996-08-02Manufacturing (CMC) · Supplement 13 · priorityAP
1995-03-07Manufacturing (CMC) · Supplement 10 · priorityAP
1994-11-10Labeling · Supplement 11 · standardAP
1994-05-09Manufacturing (CMC) · Supplement 9 · priorityAP
1994-05-09Manufacturing (CMC) · Supplement 8 · priorityAP
1993-03-19Manufacturing (CMC) · Supplement 7 · priorityAP
1993-03-19Manufacturing (CMC) · Supplement 3 · priorityAP
1993-03-19Manufacturing (CMC) · Supplement 4 · priorityAP
1992-02-21Manufacturing (CMC) · Supplement 6 · priorityAP
1991-06-10Labeling · Supplement 5AP
1983-11-14Type 1 - New Molecular Entity · Original · priorityAP
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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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