Details for New Drug Application (NDA): 062874

NDA 062874 describes NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, which is a drug marketed by Amneal, Bausch And Lomb, Sandoz, Saptalis Pharms, and Sciegen Pharms Inc, and is included in eight 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. Fifteen suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.

Summary for 062874

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

Pharmacology for NDA: 062874

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 062874

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	SUSPENSION/DROPS;OPHTHALMIC	062874	ANDA	Sandoz Inc	61314-641	61314-641-75	7.5 mL in 1 BOTTLE, PLASTIC (61314-641-75)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date:	May 11, 1988	TE:		RLD:	No

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