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Last Updated: September 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 060733

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NDA 060733 describes BACITRACIN, which is a drug marketed by Akorn, Fresenius Kabi Usa, Mylan Asi, Pfizer, Pharmacia And Upjohn, Xellia Pharms Aps, Lilly, Perrigo Co Tennessee, Pharmaderm, Pharmafair, Combe, Naska, Apothekernes, Paddock Llc, Bausch And Lomb, and Altana, and is included in twenty-three NDAs. It is available from seven suppliers. 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 060733
Tradename:BACITRACIN
Applicant:Pharmacia And Upjohn
Ingredient:bacitracin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 060733
Medical Subject Heading (MeSH) Categories for 060733
Suppliers and Packaging for NDA: 060733
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACITRACIN bacitracin INJECTABLE;INJECTION 060733 ANDA Pharmacia and Upjohn Company LLC 0009-0233 0009-0233-44 1 VIAL in 1 CARTON (0009-0233-44) > 10 mL in 1 VIAL
BACITRACIN bacitracin INJECTABLE;INJECTION 060733 ANDA Pharmacia and Upjohn Company LLC 0009-0233 0009-0233-45 10 VIAL in 1 CARTON (0009-0233-45) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10,000 UNITS/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50,000 UNITS/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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