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Generated: April 26, 2017

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Details for New Drug Application (NDA): 206589

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NDA 206589 describes POLYMYXIN B SULFATE, which is a drug marketed by X Gen Pharms, West-ward Pharms Int, Gland Pharma Ltd, Paddock Llc, Xellia Pharms Aps, Fresenius Kabi Usa, and Aurobindo Pharma Ltd, and is included in seven NDAs. It is available from six 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 eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.

Summary for NDA: 206589

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 206589

Ingredient-typePolymyxins

Suppliers and Packaging for NDA: 206589

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLYMYXIN B SULFATE
polymyxin b sulfate
INJECTABLE;INJECTION 206589 ANDA AuroMedics Pharma LLC 55150-234 55150-234-10 10 VIAL in 1 CARTON (55150-234-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500,000 UNITS BASE/VIAL
Approval Date:Apr 4, 2016TE:APRLD:No


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