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Details for New Drug Application (NDA): 078595

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NDA 078595 describes FLUMAZENIL, which is a drug marketed by Hikma Farmaceutica, Claris, Fresenius Kabi Usa, Eurohlth Intl Sarl, Sandoz, Sagent Pharms, Teva Pharms Usa, and Mylan Labs Ltd, and is included in nine NDAs. It is available from sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the flumazenil profile page.

Summary for NDA: 078595

Mylan Labs Ltd
Formulation / Manufacturing:see details

Pharmacology for NDA: 078595

Suppliers and Packaging for NDA: 078595

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
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:Yes

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