Details for New Drug Application (NDA): 062423

NDA 062423 describes NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, which is a drug marketed by Amring Pharms, Bausch And Lomb, and Sandoz, and is included in six NDAs. It is available from twelve suppliers. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE profile page.

The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE is hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are sixty-seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.

Summary for 062423

Tradename:	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Applicant:	Sandoz
Ingredient:	hydrocortisone; neomycin sulfate; polymyxin b sulfate
Patents:	0

Pharmacology for NDA: 062423

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 062423

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	hydrocortisone; neomycin sulfate; polymyxin b sulfate	SOLUTION/DROPS;OTIC	062423	ANDA	RPK Pharmaceuticals, Inc.	53002-9060	53002-9060-1	10 mL in 1 BOTTLE (53002-9060-1)
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	hydrocortisone; neomycin sulfate; polymyxin b sulfate	SOLUTION/DROPS;OTIC	062423	ANDA	Sandoz Inc	61314-646	61314-646-10	1 BOTTLE in 1 CARTON (61314-646-10) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OTIC			Strength	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date:	Aug 25, 1983	TE:	AT	RLD:	No

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