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Details for New Drug Application (NDA): 050023

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NDA 050023 describes MAXITROL, which is a drug marketed by Alcon Labs Inc and Alcon 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-eight drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the dexamethasone; neomycin sulfate; polymyxin b sulfate profile page.

Summary for NDA: 050023

Tradename:
MAXITROL
Applicant:
Alcon Labs Inc
Ingredient:
dexamethasone; neomycin sulfate; polymyxin b sulfate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 050023

Suppliers and Packaging for NDA: 050023

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAXITROL
dexamethasone; neomycin sulfate; polymyxin b sulfate
SUSPENSION/DROPS;OPHTHALMIC 050023 NDA Alcon Laboratories, Inc. 0998-0630 0998-0630-06 5 mL in 1 BOTTLE, PLASTIC (0998-0630-06)

Summary for product number 002

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


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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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