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Details for New Drug Application (NDA): 050818

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NDA 050818 describes TOBRADEX ST, which is a drug marketed by Alcon Pharms Ltd 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-eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.

Summary for NDA: 050818

Tradename:
TOBRADEX ST
Applicant:
Alcon Pharms Ltd
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 0065-0652-01 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.05%;0.3%
Approval Date:Feb 13, 2009TE:RLD:Yes
Patent:8,450,287Patent Expiration:Dec 19, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:7,795,316Patent 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:8,101,582Patent 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

Expired Orange Book Patents for NDA: 050818

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon Pharms Ltd
TOBRADEX ST
dexamethasone; tobramycin
SUSPENSION/DROPS;OPHTHALMIC050818-001Feb 13, 20095,149,694► subscribe
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