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FDA NDA · NDA050818

TOBRADEX ST

tobramycin / dexamethasone

Sponsor: HARROW EYE

APPLICATION
NDA050818
TYPE
NDA
ORIGINAL APPROVAL
2009-02-13
LATEST ACTION
2026-03-17
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

TOBRADEX ST · ReferencePrescription
DEXAMETHASONE 0.05%, TOBRAMYCIN 0.3% · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2026-03-17Labeling · Supplement 10 · standard — Label ↗AP
2022-08-16Labeling · Supplement 9 · standard — Letter ↗AP
2022-08-16Labeling · Supplement 7 · standard — Letter ↗AP
2022-08-16Labeling · Supplement 8 · standard — Letter ↗AP
2010-08-03Labeling · Supplement 1 · standard — Label ↗AP
2009-02-13Type 3 - New Dosage Form · Original · standard — Label ↗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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