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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 061212

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NDA 061212 describes BACITRACIN, which is a drug marketed by Lilly, Padagis Us, Pharmaderm, Pharmafair, Combe, Naska, Apothekernes, Paddock Llc, Bausch And Lomb, Sciegen Pharms Inc, and Altana, and is included in seventeen NDAs. It is available from one supplier. Additional details are available on the BACITRACIN profile page.

The generic ingredient in BACITRACIN is bacitracin zinc; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bacitracin zinc; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate profile page.

Summary for 061212

Tradename:	BACITRACIN
Applicant:	Padagis Us
Ingredient:	bacitracin
Patents:	0

Pharmacology for NDA: 061212

Physiological Effect	Decreased Cell Wall Synthesis & Repair

Medical Subject Heading (MeSH) Categories for 061212

Anti-Bacterial Agents
Anti-Infective Agents, Local

Suppliers and Packaging for NDA: 061212

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BACITRACIN	bacitracin	OINTMENT;OPHTHALMIC	061212	ANDA	Padagis US LLC	0574-4022	0574-4022-35	1 TUBE in 1 CARTON (0574-4022-35) / 3.5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;OPHTHALMIC			Strength	500 UNITS/GM
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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