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Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050417

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NDA 050417 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. Six suppliers are listed for this compound. Additional details are available on the gramicidin; neomycin sulfate; polymyxin b sulfate profile page.

Summary for NDA: 050417

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 050417

Suppliers and Packaging for NDA: 050417

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOSPORIN
bacitracin zinc; neomycin sulfate; polymyxin b sulfate
OINTMENT;OPHTHALMIC 050417 NDA Citron Pharma LLC 57237-129 57237-129-53 1 TUBE in 1 CARTON (57237-129-53) > 3.5 g in 1 TUBE
NEOSPORIN
bacitracin zinc; neomycin sulfate; polymyxin b sulfate
OINTMENT;OPHTHALMIC 050417 NDA Casper Pharma LLC 70199-010 70199-010-53 1 TUBE in 1 CARTON (70199-010-53) > 3.5 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes


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Serving 500+ biopharmaceutical companies globally:

McKesson
McKinsey
Fuji
UBS
Medtronic
Julphar
Cerilliant
Healthtrust
Federal Trade Commission
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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