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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 050628

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NDA 050628 describes TOBRASONE, which is a drug marketed by Harrow Eye and is included in one NDA. Additional details are available on the TOBRASONE profile page.

The generic ingredient in TOBRASONE is fluorometholone acetate; tobramycin. There are five drug master file entries for this compound. Additional details are available on the fluorometholone acetate; tobramycin profile page.

Summary for 050628

Tradename:	TOBRASONE
Applicant:	Harrow Eye
Ingredient:	fluorometholone acetate; tobramycin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.1%;0.3%
Approval Date:	Jul 21, 1989	TE:		RLD:	No

Expired US Patents for NDA 050628

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	TOBRASONE	fluorometholone acetate; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050628-001	Jul 21, 1989	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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