Last Updated: November 9, 2026

Details for New Drug Application (NDA): 060716

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NDA 060716 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 is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.

Summary for 060716

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

Pharmacology for NDA: 060716

Medical Subject Heading (MeSH) Categories for 060716

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 060716

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	060716	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9941	0143-9941-10	10 VIAL in 1 CARTON (0143-9941-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9941-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500,000 UNITS BASE/VIAL
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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