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Serving leading biopharmaceutical companies globally:

Medtronic
Fuji
Fish and Richardson
Chinese Patent Office
Accenture
Teva
QuintilesIMS
Deloitte
Farmers Insurance
Covington

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076755

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NDA 076755 describes FLUMAZENIL, which is a drug marketed by Hikma Farmaceutica, Baxter Hlthcare Corp, Fresenius Kabi Usa, West-ward Pharms Int, Sandoz Inc, Sagent Pharms, Teva Pharms Usa, and Mylan Labs Ltd, 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 NDA: 076755

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 Claris Lifesciences Inc. 36000-148 36000-148-05 5 VIAL, MULTI-DOSE in 1 PACKAGE (36000-148-05) > 5 mL in 1 VIAL, MULTI-DOSE
FLUMAZENIL
flumazenil
INJECTABLE;INJECTION 076755 ANDA Claris Lifesciences Inc. 36000-148 36000-148-10 10 VIAL, MULTI-DOSE in 1 PACKAGE (36000-148-10) > 5 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

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

Summary 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 leading biopharmaceutical companies globally:

Healthtrust
Fuji
Mallinckrodt
Cipla
Dow
Julphar
Harvard Business School
UBS
AstraZeneca
Baxter

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