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FDA NDA · NDA050514

NATACYN

natamycin

Sponsor: HARROW EYE

APPLICATION
NDA050514
TYPE
NDA
ORIGINAL APPROVAL
1978-10-30
LATEST ACTION
2025-11-17
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

NATACYN · ReferencePrescription
NATAMYCIN 5% · SUSPENSION · OPHTHALMIC

Approval history

2025-11-17Labeling · Supplement 22 · standard — Label ↗AP
2008-07-18Labeling · Supplement 9 · standard — Review ↗AP
2002-12-04Manufacturing (CMC) · Supplement 10 · priorityAP
2000-10-19Manufacturing (CMC) · Supplement 8 · priorityAP
1997-05-02Manufacturing (CMC) · Supplement 7 · priorityAP
1995-11-01Manufacturing (CMC) · Supplement 6 · priorityAP
1992-06-30Labeling · Supplement 4AP
1992-02-10Manufacturing (CMC) · Supplement 5 · priorityAP
1991-03-08Manufacturing (CMC) · Supplement 3 · priorityAP
1978-10-30Type 3 - New Dosage Form · Original · priorityAP
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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