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Details for New Drug Application (NDA): 062166

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NDA 062166 describes BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, which is a drug marketed by Altana and Perrigo Co Tennessee and is included in two NDAs. It is available from three suppliers. Additional details are available on the BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE profile page.

The generic ingredient in BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE is bacitracin; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bacitracin; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate profile page.

Pharmacology for NDA: 062166

Suppliers and Packaging for NDA: 062166

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
bacitracin; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate
OINTMENT;OPHTHALMIC 062166 ANDA Paddock Laboratories, LLC 0574-4144 0574-4144-35 1 TUBE in 1 CARTON (0574-4144-35) > 3.5 g in 1 TUBE
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
bacitracin; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate
OINTMENT;OPHTHALMIC 062166 ANDA Rebel Distributors Corp 21695-736 21695-736-35 3.5 g in 1 TUBE (21695-736-35)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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