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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 063000


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NDA 063000 describes POLYMYXIN B SULFATE, which is a drug marketed by Beowulf Asset, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Rising, Xellia Pharms Aps, and Paddock Llc, and is included in eight NDAs. It is available from seven 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. Seven 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:Beowulf Asset
Ingredient:polymyxin b sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 063000
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 XGen Pharmaceuticals DJB, Inc. 39822-0166 39822-0166-5 1 VIAL in 1 CARTON (39822-0166-5) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 063000 ANDA XGen Pharmaceuticals DJB, Inc. 39822-0166 39822-0166-7 1 VIAL in 1 CARTON (39822-0166-7) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

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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