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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 050616

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NDA 050616 describes TOBRADEX, which is a drug marketed by Novartis, Sandoz, and Harrow Eye, and is included in three NDAs. It is available from six suppliers. There are three patents protecting this drug. Additional details are available on the TOBRADEX profile page.

The generic ingredient in TOBRADEX 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 050616

Tradename:	TOBRADEX
Applicant:	Novartis
Ingredient:	dexamethasone; tobramycin
Patents:	0

Pharmacology for NDA: 050616

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 050616

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOBRADEX	dexamethasone; tobramycin	OINTMENT;OPHTHALMIC	050616	NDA	Novartis Pharmaceuticals Corporation	0078-0876	0078-0876-01	3.5 g in 1 TUBE (0078-0876-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;OPHTHALMIC			Strength	0.1%;0.3%
Approval Date:	Sep 28, 1988	TE:		RLD:	Yes

Expired US Patents for NDA 050616

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TOBRADEX	dexamethasone; tobramycin	OINTMENT;OPHTHALMIC	050616-001	Sep 28, 1988	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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