FDA NDA · NDA021737

RETISERT

fluocinolone acetonide

Sponsor: BAUSCH AND LOMB

APPLICATION

NDA021737

TYPE

NDA

ORIGINAL APPROVAL

2005-04-08

LATEST ACTION

2025-04-04

ROUTE

INTRAVITREAL

DOSAGE FORM

IMPLANT

MARKETING STATUS

Discontinued

Products

RETISERT · ReferenceDiscontinued

FLUOCINOLONE ACETONIDE 0.59MG · IMPLANT · INTRAVITREAL

2025-04-04Labeling · Supplement 26 · standard — Label ↗AP

2015-03-30Manufacturing (CMC) · Supplement 22 · priorityAP

2014-06-20Manufacturing (CMC) · Supplement 21 · priorityAP

2011-06-02Manufacturing (CMC) · Supplement 19 — Letter ↗AP

2010-11-30Manufacturing (CMC) · Supplement 18 · priority — Letter ↗AP

2008-08-05Efficacy · Supplement 10 · unknown — Letter ↗AP

2007-10-30Labeling · Supplement 7 · standard — Label ↗AP

2005-04-08Type 3 - New Dosage Form · 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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