Details for New Drug Application (NDA): 050818

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NDA 050818 describes TOBRADEX ST, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the TOBRADEX ST profile page.

The generic ingredient in TOBRADEX ST is dexamethasone; tobramycin. There are thirty-nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.

Summary for 050818

Tradename:	TOBRADEX ST
Applicant:	Harrow Eye
Ingredient:	dexamethasone; tobramycin
Patents:	3

Pharmacology for NDA: 050818

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 050818

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818	NDA	Eyevance Pharmaceuticals, LLC	71776-035	71776-035-01	1 BOTTLE, DROPPER in 1 CARTON (71776-035-01) / 1 mL in 1 BOTTLE, DROPPER
TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818	NDA	Eyevance Pharmaceuticals, LLC	71776-035	71776-035-05	1 BOTTLE, DROPPER in 1 CARTON (71776-035-05) / 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.05%;0.3%
Approval Date:	Feb 13, 2009	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Aug 3, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
Patent:	⤷ Subscribe	Patent Expiration:	Dec 19, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
Patent:	⤷ Subscribe	Patent Expiration:	Dec 19, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 050818

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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