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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 206589

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NDA 206589 describes POLYMYXIN B SULFATE, which is a drug marketed by Adrastea Pharma, 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 206589

Tradename:	POLYMYXIN B SULFATE
Applicant:	Eugia Pharma
Ingredient:	polymyxin b sulfate
Patents:	0

Pharmacology for NDA: 206589

Medical Subject Heading (MeSH) Categories for 206589

Anti-Bacterial Agents

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	Eugia US LLC	55150-234	55150-234-10	10 VIAL in 1 CARTON (55150-234-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500,000 UNITS BASE/VIAL
Approval Date:	Apr 4, 2016	TE:	AP	RLD:	No

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