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Covington
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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065372

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NDA 065372 describes POLYMYXIN B SULFATE, which is a drug marketed by Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, West-ward Pharms Int, X Gen Pharms, Xellia Pharms Aps, and Paddock Llc, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the POLYMYXIN B SULFATE profile page.

The generic ingredient in POLYMYXIN B SULFATE is polymyxin b sulfate. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.
Summary for 065372
Tradename:POLYMYXIN B SULFATE
Applicant:Fresenius Kabi Usa
Ingredient:polymyxin b sulfate
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065372
Ingredient-typePolymyxins
Medical Subject Heading (MeSH) Categories for 065372
Suppliers and Packaging for NDA: 065372
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 065372 ANDA Fresenius Kabi USA, LLC 63323-321 N 63323-321-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500,000 UNITS BASE/VIAL
Approval Date:Jan 10, 2008TE:APRLD:No

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