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Last Updated: November 23, 2020

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 Eyevance 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. Five suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.
Summary for 050818
Tradename:TOBRADEX ST
Applicant:Eyevance
Ingredient:dexamethasone; tobramycin
Patents:3
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 0065-0652-01 1 BOTTLE, DROPPER in 1 CARTON (0065-0652-01) > 1 mL in 1 BOTTLE, DROPPER
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

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Moodys
Medtronic
Express Scripts
Merck

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