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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050818

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NDA 050818 describes TOBRADEX ST, which is a drug marketed by Novartis Pharms Corp 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. Nine suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.
Summary for 050818
Tradename:TOBRADEX ST
Applicant:Novartis Pharms Corp
Ingredient:dexamethasone; tobramycin
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 050818
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 Alcon Laboratories, Inc. 0065-0652 0065-0652-05 1 BOTTLE, DROPPER in 1 CARTON (0065-0652-05) > 5 mL in 1 BOTTLE, DROPPER
TOBRADEX ST dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050818 NDA Alcon Laboratories, Inc. 0065-0652 0065-0652-01 1 BOTTLE, DROPPER in 1 CARTON (0065-0652-01) > 1 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.05%;0.3%
Approval Date:Feb 13, 2009TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Aug 3, 2028Product Flag?YSubstance 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:➤ SubscribePatent Expiration:Dec 19, 2027Product Flag?YSubstance 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:➤ SubscribePatent Expiration:Dec 19, 2027Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Baxter
Colorcon
McKesson
Harvard Business School
Moodys
Merck
Argus Health

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