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Harvard Business School
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Colorcon
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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090584

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NDA 090584 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: 090584

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

Pharmacology for NDA: 090584

Suppliers and Packaging for NDA: 090584

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUMAZENIL
flumazenil
INJECTABLE;INJECTION 090584 ANDA Sagent Pharmaceuticals 25021-600 25021-600-05 10 VIAL in 1 CARTON (25021-600-05) > 5 mL in 1 VIAL
FLUMAZENIL
flumazenil
INJECTABLE;INJECTION 090584 ANDA Sagent Pharmaceuticals 25021-600 25021-600-10 10 VIAL in 1 CARTON (25021-600-10) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5MG/5ML (0.1MG/ML)
Approval Date:Aug 28, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/10ML (0.1MG/ML)
Approval Date:Aug 28, 2012TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

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Cipla

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