Details for New Drug Application (NDA): 062341

NDA 062341 describes MAXITROL, which is a drug marketed by Sandoz and Harrow Eye and is included in three NDAs. It is available from nine 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. Seventeen suppliers are listed for this compound. Additional details are available on the dexamethasone; neomycin sulfate; polymyxin b sulfate profile page.

Summary for 062341

Tradename:	MAXITROL
Applicant:	Sandoz
Ingredient:	dexamethasone; neomycin sulfate; polymyxin b sulfate
Patents:	0

Pharmacology for NDA: 062341

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

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	RPK Pharmaceuticals, Inc.	53002-9511	53002-9511-1	5 mL in 1 BOTTLE, DROPPER (53002-9511-1)
MAXITROL	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	062341	ANDA	Sandoz Inc.	61314-630	61314-630-06	5 mL in 1 BOTTLE, PLASTIC (61314-630-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date:	May 22, 1984	TE:	AT	RLD:	No

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