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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Harvard Business School
McKinsey
QuintilesIMS
Daiichi Sankyo
Medtronic
Accenture
Cantor Fitzgerald

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050065

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NDA 050065 describes MAXITROL, which is a drug marketed by Novartis Pharms Corp and Sandoz Inc and is included in three NDAs. It is available from six suppliers. Additional details are available on the MAXITROL profile page.

The generic ingredient in MAXITROL is dexamethasone; neomycin sulfate; polymyxin b sulfate. There are thirty-nine drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the dexamethasone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 050065
Tradename:MAXITROL
Applicant:Novartis Pharms Corp
Ingredient:dexamethasone; neomycin sulfate; polymyxin b sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050065
Suppliers and Packaging for NDA: 050065
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050065 NDA Alcon Laboratories, Inc. 0065-0631 N 0065-0631-36
MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050065 NDA AUTHORIZED GENERIC Sandoz Inc 61314-631 N 61314-631-36

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Cipla
Fish and Richardson
Johnson and Johnson
Julphar
Farmers Insurance
Merck
Cantor Fitzgerald
Daiichi Sankyo

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