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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Novartis
Cipla
Healthtrust
Federal Trade Commission
Boehringer Ingelheim
AstraZeneca
Covington
Express Scripts
Citi

Generated: June 29, 2017

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 five 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-one suppliers are listed for this compound. Additional details are available on the dexamethasone; neomycin sulfate; polymyxin b sulfate profile page.

Summary for NDA: 050065

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 0065-0631-36 3.5 g in 1 TUBE (0065-0631-36)
MAXITROL
dexamethasone; neomycin sulfate; polymyxin b sulfate
OINTMENT;OPHTHALMIC 050065 NDA AUTHORIZED GENERIC Falcon Pharmaceuticals, Ltd. 61314-631 61314-631-36 3.5 g in 1 TUBE (61314-631-36)

Summary 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 500+ biopharmaceutical companies globally:

Harvard Business School
Chubb
Johnson and Johnson
US Army
Boehringer Ingelheim
Queensland Health
Dow
Julphar
US Department of Justice
Chinese Patent Office

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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