← FDA DRUG APPROVALS

FDA NDA · NDA050625

SANDIMMUNE

cyclosporine

Sponsor: NOVARTIS

APPLICATION
NDA050625
TYPE
NDA
ORIGINAL APPROVAL
1990-03-02
LATEST ACTION
2026-03-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

SANDIMMUNE · ReferencePrescription
CYCLOSPORINE 100MG · CAPSULE · ORAL
SANDIMMUNE · ReferencePrescription
CYCLOSPORINE 50MG · CAPSULE · ORAL
SANDIMMUNE · ReferencePrescription
CYCLOSPORINE 25MG · CAPSULE · ORAL

Approval history

2026-03-06Labeling · Supplement 65 · standard — Letter ↗AP
2023-09-28Labeling · Supplement 61 · standard — Label ↗AP
2022-03-16Manufacturing (CMC) · Supplement 60 — Letter ↗AP
2016-01-06Manufacturing (CMC) · Supplement 57 · priorityAP
2015-03-31Labeling · Supplement 55 · standard — Label ↗AP
2013-05-03Labeling · Supplement 53 · standard — Label ↗AP
2012-08-30Labeling · Supplement 49 · standard — Letter ↗AP
2010-04-30Labeling · Supplement 48 · unknown — Label ↗AP
2009-10-08Labeling · Supplement 47 · unknown — Label ↗AP
2007-07-20Manufacturing (CMC) · Supplement 45AP
2006-03-06Labeling · Supplement 44 · standard — Label ↗AP
2005-07-19Labeling · Supplement 43 · standard — Letter ↗AP
2004-02-06Labeling · Supplement 40 · standard — Label ↗AP
2004-02-06Labeling · Supplement 39 · standard — Label ↗AP
2003-02-14Labeling · Supplement 32 · standard — Label ↗AP
2003-02-14Labeling · Supplement 30 · standard — Letter ↗AP
2002-04-12Manufacturing (CMC) · Supplement 34 · priorityAP
2002-01-16Manufacturing (CMC) · Supplement 33 · priorityAP
2000-10-04Labeling · Supplement 27 · standardAP
2000-06-30Manufacturing (CMC) · Supplement 29 · priorityAP
1999-12-21Labeling · Supplement 28 · standardAP
1998-03-30Manufacturing (CMC) · Supplement 25 · priorityAP
1996-08-09Labeling · Supplement 23 · standardAP
1996-04-15Manufacturing (CMC) · Supplement 24 · priorityAP
1995-11-21Labeling · Supplement 22 · standardAP
1995-11-21Manufacturing (CMC) · Supplement 21 · priorityAP
1995-03-07Manufacturing (CMC) · Supplement 18 · priorityAP
1995-01-13Manufacturing (CMC) · Supplement 20 · priorityAP
1994-11-10Labeling · Supplement 19 · standardAP
1994-05-09Manufacturing (CMC) · Supplement 16 · priorityAP
1994-05-09Manufacturing (CMC) · Supplement 17 · priorityAP
1993-05-17Manufacturing (CMC) · Supplement 14 · priorityAP
1993-03-19Manufacturing (CMC) · Supplement 12 · priorityAP
1992-12-30Manufacturing (CMC) · Supplement 6 · priorityAP
1992-12-30Manufacturing (CMC) · Supplement 7 · priorityAP
1992-11-23Manufacturing (CMC) · Supplement 11 · priorityAP
1992-11-02Manufacturing (CMC) · Supplement 13 · priorityAP
1992-02-21Manufacturing (CMC) · Supplement 10 · priorityAP
1991-11-21Manufacturing (CMC) · Supplement 2 · priorityAP
1991-06-10Labeling · Supplement 9AP
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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