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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Federal Trade Commission
Farmers Insurance
Harvard Business School
US Department of Justice
Boehringer Ingelheim
Chinese Patent Office

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062341

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NDA 062341 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 062341
Applicant:Sandoz Inc
Ingredient:dexamethasone; neomycin sulfate; polymyxin b sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 062341
Suppliers and Packaging for NDA: 062341
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OPHTHALMIC 062341 ANDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 49999-141 N 49999-141-05
MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OPHTHALMIC 062341 ANDA Sandoz Inc. 61314-630 N 61314-630-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date:May 22, 1984TE:ATRLD:No

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