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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078595

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NDA 078595 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 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 078595

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

Pharmacology for NDA: 078595

Medical Subject Heading (MeSH) Categories for 078595

Suppliers and Packaging for NDA: 078595

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUMAZENIL flumazenil INJECTABLE;INJECTION 078595 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0093 0069-0093-03 10 VIAL in 1 CARTON (0069-0093-03) > 10 mL in 1 VIAL (0069-0093-01)
FLUMAZENIL flumazenil INJECTABLE;INJECTION 078595 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0105 0069-0105-03 10 VIAL in 1 CARTON (0069-0105-03) > 5 mL in 1 VIAL (0069-0105-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5MG/5ML (0.1MG/ML)
Approval Date:May 13, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/10ML (0.1MG/ML)
Approval Date:May 13, 2008TE:APRLD:No


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