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FDA NDA · NDA050790

CYCLOSPORINE

Sponsor: ABBVIE

APPLICATION
NDA050790
TYPE
NDA
ORIGINAL APPROVAL
2002-12-23
LATEST ACTION
2025-08-21
ROUTE
OPHTHALMIC
DOSAGE FORM
EMULSION
MARKETING STATUS
Prescription

Products

RESTASIS MULTIDOSE · ReferencePrescription
CYCLOSPORINE 0.05% · EMULSION · OPHTHALMIC
RESTASIS · ReferencePrescription
CYCLOSPORINE 0.05% · EMULSION · OPHTHALMIC

Approval history

2025-08-21Labeling · Supplement 31 · standard — Letter ↗AP
2017-07-18Labeling · Supplement 27 · standard — Label ↗AP
2016-10-27Labeling · Supplement 25 · standard — Label ↗AP
2016-10-27Manufacturing (CMC) · Supplement 24 · standard — Label ↗AP
2014-01-16Manufacturing (CMC) · Supplement 22 · priorityAP
2013-12-05Manufacturing (CMC) · Supplement 23 · priorityAP
2013-05-31Manufacturing (CMC) · Supplement 21 · priority — Label ↗AP
2013-01-16Manufacturing (CMC) · Supplement 19 · priorityAP
2012-12-03Labeling · Supplement 20 · standard — Label ↗AP
2007-12-27Manufacturing (CMC) · Supplement 13AP
2003-10-01Labeling · Supplement 4 · standard — Letter ↗AP
2003-10-01Manufacturing (CMC) · Supplement 3 · priority — Letter ↗AP
2003-09-16Labeling · Supplement 1 · standard — Letter ↗AP
2003-09-12Manufacturing (CMC) · Supplement 2 · priority — Review ↗AP
2002-12-23Type 3 - New Dosage Form · Original · priority — Review ↗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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