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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 202766

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NDA 202766 describes POLYMYXIN B SULFATE, which is a drug marketed by Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Pharmobedient, 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 202766

Tradename:	POLYMYXIN B SULFATE
Applicant:	Xellia Pharms Aps
Ingredient:	polymyxin b sulfate
Patents:	0

Pharmacology for NDA: 202766

Medical Subject Heading (MeSH) Categories for 202766

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 202766

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	202766	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9461	0143-9461-01	1 VIAL, GLASS in 1 CARTON (0143-9461-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	202766	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9461	0143-9461-10	10 VIAL, GLASS in 1 CARTON (0143-9461-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500,000 UNITS BASE/VIAL
Approval Date:	Jan 15, 2014	TE:	AP	RLD:	No

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