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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Dow
UBS
US Department of Justice
Fuji
US Army
Citi
McKesson

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076755

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NDA 076755 describes FLUMAZENIL, which is a drug marketed by Baxter Hlthcare Corp, Fresenius Kabi Usa, Hikma Farmaceutica, Mylan Labs Ltd, Sagent Pharms, Sandoz Inc, Teva Pharms Usa, and West-ward Pharms Int, and is included in nine NDAs. It is available from fifteen suppliers. Additional details are available on the FLUMAZENIL profile page.

The generic ingredient in FLUMAZENIL is flumazenil. There are four drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the flumazenil profile page.
Summary for 076755
Tradename:FLUMAZENIL
Applicant:Baxter Hlthcare Corp
Ingredient:flumazenil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076755
Medical Subject Heading (MeSH) Categories for 076755
Suppliers and Packaging for NDA: 076755
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUMAZENIL flumazenil INJECTABLE;INJECTION 076755 ANDA Baxter Healthcare Corporation 36000-148 N 36000-148-10
FLUMAZENIL flumazenil INJECTABLE;INJECTION 076755 ANDA Baxter Healthcare Corporation 36000-149 N 36000-149-10

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1MG/10ML (0.1MG/ML)
Approval Date:Oct 12, 2004TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.5MG/5ML (0.1MG/ML)
Approval Date:Oct 12, 2004TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
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