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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 061229

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NDA 061229 describes POLYSPORIN, which is a drug marketed by Glaxosmithkline and Monarch Pharms and is included in two NDAs. Additional details are available on the POLYSPORIN profile page.

The generic ingredient in POLYSPORIN is bacitracin zinc; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the bacitracin zinc; polymyxin b sulfate profile page.

Summary for 061229

Tradename:	POLYSPORIN
Applicant:	Monarch Pharms
Ingredient:	bacitracin zinc; polymyxin b sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;OPHTHALMIC			Strength	500 UNITS/GM;10,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for s or e reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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