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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064053

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NDA 064053 describes NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, which is a drug marketed by Amring Pharms, Bausch And Lomb, and Sandoz Inc, and is included in six NDAs. It is available from fourteen 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-four drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 064053
Pharmacology for NDA: 064053
Suppliers and Packaging for NDA: 064053
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 064053 ANDA Blenheim Pharmacal, Inc 10544-912 E 10544-912-99
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE hydrocortisone; neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OTIC 064053 ANDA Rebel Distributors Corp 21695-437 E 21695-437-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date:Dec 29, 1995TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
US Army
Dow
Deloitte
Colorcon
Queensland Health
Merck
Covington
Cantor Fitzgerald

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