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Generated: May 23, 2017

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Details for New Drug Application (NDA): 062664

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NDA 062664 describes NEOMYCIN AND POLYMYXIN B SULFATE, which is a drug marketed by X Gen Pharms, Watson Labs, Bausch And Lomb, Perrigo Co Tennessee, Akorn, Alcon Pharms Ltd, Ipharm, Amring Pharms, and Sandoz Inc, and is included in twenty-one NDAs. It is available from two suppliers. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATE profile page.

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

Summary for NDA: 062664

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

Pharmacology for NDA: 062664

Suppliers and Packaging for NDA: 062664

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOMYCIN AND POLYMYXIN B SULFATE
neomycin sulfate; polymyxin b sulfate
SOLUTION;IRRIGATION 062664 ANDA Watson Laboratories, Inc. 0591-2190 0591-2190-45 10 AMPULE in 1 CARTON (0591-2190-45) > 1 mL in 1 AMPULE (0591-2190-54)
NEOMYCIN AND POLYMYXIN B SULFATE
neomycin sulfate; polymyxin b sulfate
SOLUTION;IRRIGATION 062664 ANDA Watson Laboratories, Inc. 0591-2190 0591-2190-50 50 AMPULE in 1 CARTON (0591-2190-50) > 1 mL in 1 AMPULE (0591-2190-54)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrengthEQ 40MG BASE/ML;200,000 UNITS/ML
Approval Date:Apr 8, 1986TE:ATRLD:No


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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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