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FDA NDA · NDA050574

SANDIMMUNE

Sponsor: NOVARTIS

APPLICATION
NDA050574
TYPE
NDA
ORIGINAL APPROVAL
1983-11-14
LATEST ACTION
2026-05-29
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SANDIMMUNE · ReferencePrescription
CYCLOSPORINE 100MG/ML · SOLUTION · ORAL

Approval history

2026-05-29Labeling · Supplement 59 · standard — Label ↗AP
2026-03-06Labeling · Supplement 60 · standard — Letter ↗AP
2023-09-28Labeling · Supplement 57 · standard — Label ↗AP
2016-07-14Manufacturing (CMC) · Supplement 52 · priorityAP
2015-03-31Labeling · Supplement 51 · standard — Label ↗AP
2014-01-22Manufacturing (CMC) · Supplement 49 · priorityAP
2013-05-03Labeling · Supplement 47 · standard — Label ↗AP
2012-08-30Labeling · Supplement 43 · standard — Label ↗AP
2010-04-30Labeling · Supplement 42 · unknown — Label ↗AP
2009-10-08Labeling · Supplement 41 · unknown — Label ↗AP
2006-03-06Labeling · Supplement 40 · standard — Label ↗AP
2005-07-19Labeling · Supplement 39 · standard — Letter ↗AP
2004-02-06Labeling · Supplement 37 · standard — Label ↗AP
2004-02-06Labeling · Supplement 35 · standard — Label ↗AP
2003-02-14Labeling · Supplement 29 · standard — Label ↗AP
2003-02-14Labeling · Supplement 27 · standard — Label ↗AP
2002-06-14Manufacturing (CMC) · Supplement 32 · priorityAP
2002-04-12Manufacturing (CMC) · Supplement 33 · priorityAP
2002-02-22Manufacturing (CMC) · Supplement 30 · priorityAP
2002-01-16Manufacturing (CMC) · Supplement 31 · priorityAP
2001-11-16Manufacturing (CMC) · Supplement 28 · priorityAP
2000-10-04Labeling · Supplement 25 · standardAP
1999-12-21Labeling · Supplement 26 · standardAP
1999-05-13Manufacturing (CMC) · Supplement 24 · priorityAP
1998-10-20Manufacturing (CMC) · Supplement 23 · priorityAP
1998-07-27Manufacturing (CMC) · Supplement 22 · priorityAP
1998-03-30Manufacturing (CMC) · Supplement 20 · priorityAP
1998-01-30Manufacturing (CMC) · Supplement 21 · priorityAP
1996-08-09Labeling · Supplement 18 · standardAP
1996-03-22Manufacturing (CMC) · Supplement 19 · priorityAP
1995-11-21Labeling · Supplement 17 · standardAP
1995-04-28Manufacturing (CMC) · Supplement 16 · priorityAP
1995-03-07Manufacturing (CMC) · Supplement 14 · priorityAP
1994-11-10Labeling · Supplement 15 · standardAP
1994-05-19Manufacturing (CMC) · Supplement 13 · priorityAP
1994-05-09Manufacturing (CMC) · Supplement 12 · priorityAP
1994-05-09Manufacturing (CMC) · Supplement 11 · priorityAP
1993-03-19Manufacturing (CMC) · Supplement 10 · priorityAP
1993-02-24Manufacturing (CMC) · Supplement 4 · priorityAP
1993-02-16Manufacturing (CMC) · Supplement 3 · priorityAP
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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