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Serving leading biopharmaceutical companies globally:

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US Army
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Express Scripts

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050592

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NDA 050592 describes TOBRADEX, which is a drug marketed by Novartis Pharms Corp and is included in three NDAs. It is available from four 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. Eight suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.
Summary for 050592
Applicant:Novartis Pharms Corp
Ingredient:dexamethasone; tobramycin
Formulation / Manufacturing:see details
Pharmacology for NDA: 050592
Suppliers and Packaging for NDA: 050592
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRADEX dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050592 NDA Alcon Laboratories, Inc. 0065-0647 N 0065-0647-25
TOBRADEX dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050592 NDA Alcon Laboratories, Inc. 0065-0647 N 0065-0647-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.1%;0.3%
Approval Date:Aug 18, 1988TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

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