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Serving leading biopharmaceutical companies globally:

US Army
Chinese Patent Office
Queensland Health
Fish and Richardson
Harvard Business School

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 060582

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NDA 060582 describes NEOSPORIN, which is a drug marketed by Casper Pharma Llc, Glaxosmithkline, and Monarch Pharms, and is included in four NDAs. It is available from three suppliers. Additional details are available on the NEOSPORIN profile page.

The generic ingredient in NEOSPORIN is gramicidin; neomycin sulfate; polymyxin b sulfate. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the gramicidin; neomycin sulfate; polymyxin b sulfate profile page.

Summary for NDA: 060582

Formulation / Manufacturing:see details

Pharmacology for NDA: 060582

Suppliers and Packaging for NDA: 060582

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
gramicidin; neomycin sulfate; polymyxin b sulfate
SOLUTION/DROPS;OPHTHALMIC 060582 ANDA Pfizer Laboratories Div Pfizer Inc 61570-045 61570-045-10 1 BOTTLE, DISPENSING in 1 CARTON (61570-045-10) > 10 mL in 1 BOTTLE, DISPENSING

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Johnson and Johnson
US Department of Justice
Daiichi Sankyo
Express Scripts

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