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Covington
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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076589

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NDA 076589 describes FLUMAZENIL, which is a drug marketed by Hikma Farmaceutica, Claris, 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 thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the flumazenil profile page.

Summary for NDA: 076589

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

Pharmacology for NDA: 076589

Suppliers and Packaging for NDA: 076589

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUMAZENIL
flumazenil
INJECTABLE;INJECTION 076589 ANDA Physicians Total Care, Inc. 54868-5715 54868-5715-0 10 VIAL, MULTI-DOSE in 1 TRAY (54868-5715-0) > 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 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
McKinsey
US Army
Cipla
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Mallinckrodt
Julphar
Accenture
Queensland Health

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