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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 063000

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NDA 063000 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 063000
Tradename:POLYMYXIN B SULFATE
Applicant:X Gen Pharms
Ingredient:polymyxin b sulfate
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 063000
Ingredient-typePolymyxins
Medical Subject Heading (MeSH) Categories for 063000
Suppliers and Packaging for NDA: 063000
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 063000 ANDA X-GEN Pharmaceuticals, Inc. 39822-0166 N 39822-0166-5
POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 063000 ANDA X-GEN Pharmaceuticals, Inc. 39822-0166 N 39822-0166-7

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500,000 UNITS BASE/VIAL
Approval Date:Sep 30, 1994TE:APRLD:No

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