Bacitracin zinc; polymyxin b sulfate - Generic Drug Details

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What are the generic sources for bacitracin zinc; polymyxin b sulfate and what is the scope of freedom to operate?

Bacitracin zinc; polymyxin b sulfate is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Bausch And Lomb, Padagis Us, Sciegen Pharms Inc, Pharmafair, Monarch Pharms, and Naska, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Seven suppliers are listed for this compound.

Sponsor	Phase
Glaxo Wellcome	N/A
National Institute of Allergy and Infectious Diseases (NIAID)	N/A

Sponsor

Phase

Glaxo Wellcome

N/A

National Institute of Allergy and Infectious Diseases (NIAID)

N/A

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	BACITRACIN ZINC AND POLYMYXIN B SULFATE	bacitracin zinc; polymyxin b sulfate	OINTMENT;OPHTHALMIC	064046-001	Jan 26, 1995	AT	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Monarch Pharms	POLYSPORIN	bacitracin zinc; polymyxin b sulfate	OINTMENT;OPHTHALMIC	061229-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Naska	BACITRACIN ZINC-POLYMYXIN B SULFATE	bacitracin zinc; polymyxin b sulfate	OINTMENT;TOPICAL	062849-001	Nov 13, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Us	BACITRACIN ZINC AND POLYMYXIN B SULFATE	bacitracin zinc; polymyxin b sulfate	OINTMENT;OPHTHALMIC	065022-001	Feb 27, 2002	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	POLYSPORIN	bacitracin zinc; polymyxin b sulfate	AEROSOL;TOPICAL	050167-002	Mar 1, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmafair	OCUMYCIN	bacitracin zinc; polymyxin b sulfate	OINTMENT;OPHTHALMIC	062430-001	Apr 8, 1983		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sciegen Pharms Inc	BACITRACIN ZINC AND POLYMYXIN B SULFATE	bacitracin zinc; polymyxin b sulfate	OINTMENT;OPHTHALMIC	064028-001	Jan 30, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	4
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	7
Clinical Trials:	1
DailyMed Link:	bacitracin zinc; polymyxin b sulfate at DailyMed

Drug Class	Polymyxin-class Antibacterial
Physiological Effect	Decreased Cell Wall Synthesis & Repair