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Serving leading biopharmaceutical companies globally:

Baxter
QuintilesIMS
AstraZeneca
Moodys
Chubb
Federal Trade Commission
Boehringer Ingelheim
Queensland Health
Dow
Merck

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065116

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NDA 065116 describes BACITRACIN, which is a drug marketed by Akorn, Fresenius Kabi Usa, Pfizer, Pharmacia And Upjohn, Sagent Strides, 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 nine suppliers. Additional details are available on the BACITRACIN profile page.

The generic ingredient in BACITRACIN 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.
Summary for 065116
Tradename:BACITRACIN
Applicant:Fresenius Kabi Usa
Ingredient:bacitracin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065116
Medical Subject Heading (MeSH) Categories for 065116
Suppliers and Packaging for NDA: 065116
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACITRACIN bacitracin INJECTABLE;INJECTION 065116 ANDA Fresenius Kabi USA, LLC 63323-329 63323-329-30 1 VIAL in 1 CARTON (63323-329-30) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
BACITRACIN bacitracin INJECTABLE;INJECTION 065116 ANDA Fresenius Kabi USA, LLC 63323-329 63323-329-31 10 VIAL in 1 CARTON (63323-329-31) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50,000 UNITS/VIAL
Approval Date:Dec 3, 2002TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Colorcon
Healthtrust
Baxter
Cerilliant
Julphar
Accenture
Johnson and Johnson
Queensland Health
Teva

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