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FDA NDA · NDA050628

TOBRASONE

Sponsor: HARROW EYE

APPLICATION
NDA050628
TYPE
NDA
ORIGINAL APPROVAL
1989-07-21
LATEST ACTION
2002-12-11
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued

Products

TOBRASONEDiscontinued
FLUOROMETHOLONE ACETATE 0.1%, TOBRAMYCIN 0.3% · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2002-12-11Manufacturing (CMC) · Supplement 4 · standardAP
2002-12-04Manufacturing (CMC) · Supplement 3 · standardAP
2001-05-09Manufacturing (CMC) · Supplement 2 · standardAP
2001-05-07Labeling · Supplement 1 · standard — Label ↗AP
1989-07-21Type 4 - New Combination · Original · standardAP
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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