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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
US Army
Queensland Health
Harvard Business School

Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076787

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NDA 076787 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 fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the flumazenil profile page.

Summary for 076787

Formulation / Manufacturing:see details

Pharmacology for NDA: 076787

Medical Subject Heading (MeSH) Categories for 076787

Suppliers and Packaging for NDA: 076787

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 076787 ANDA West-ward Pharmaceutical Corp. 0641-6031 0641-6031-10 10 VIAL in 1 CARTON (0641-6031-10) > 5 mL in 1 VIAL (0641-6031-01)
INJECTABLE;INJECTION 076787 ANDA West-ward Pharmaceutical Corp. 0641-6032 0641-6032-10 10 VIAL in 1 CARTON (0641-6032-10) > 10 mL in 1 VIAL (0641-6032-01)

Summary for product number 001

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

Summary for product number 002

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

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
Federal Trade Commission
Harvard Business School
US Department of Justice
Chinese Patent Office

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