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Serving leading biopharmaceutical companies globally:

Chubb
Julphar
McKesson
Covington
Cerilliant
QuintilesIMS
Colorcon
McKinsey
Harvard Business School
Deloitte

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050541

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NDA 050541 describes TOBREX, which is a drug marketed by Novartis Pharms Corp and Sandoz Inc and is included in three NDAs. It is available from five suppliers. Additional details are available on the TOBREX profile page.

The generic ingredient in TOBREX is tobramycin. There are eighteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 050541
Tradename:TOBREX
Applicant:Novartis Pharms Corp
Ingredient:tobramycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050541
Ingredient-typeAminoglycosides
Medical Subject Heading (MeSH) Categories for 050541
Suppliers and Packaging for NDA: 050541
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBREX tobramycin SOLUTION/DROPS;OPHTHALMIC 050541 NDA Alcon Laboratories, Inc. 0065-0643 0065-0643-05 1 BOTTLE, PLASTIC in 1 CARTON (0065-0643-05) > 5 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

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Serving leading biopharmaceutical companies globally:

Healthtrust
US Army
Covington
QuintilesIMS
Boehringer Ingelheim
Cipla
Fuji
Moodys
Medtronic

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