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Express Scripts
Boehringer Ingelheim

Last Updated: April 1, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076955

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NDA 076955 describes FLUMAZENIL, which is a drug marketed by Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Mylan Labs Ltd, Sagent Pharms, Sandoz Inc, and West-ward Pharms Int, and is included in nine NDAs. It is available from eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the flumazenil profile page.
Summary for 076955
Applicant:Fresenius Kabi Usa
Formulation / Manufacturing:see details
Pharmacology for NDA: 076955
Medical Subject Heading (MeSH) Categories for 076955
Suppliers and Packaging for NDA: 076955
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUMAZENIL flumazenil INJECTABLE;INJECTION 076955 ANDA Fresenius Kabi USA, LLC 63323-424 63323-424-05 10 VIAL, MULTI-DOSE in 1 TRAY (63323-424-05) > 5 mL in 1 VIAL, MULTI-DOSE
FLUMAZENIL flumazenil INJECTABLE;INJECTION 076955 ANDA Fresenius Kabi USA, LLC 63323-424 63323-424-10 1 VIAL, MULTI-DOSE in 1 CARTON (63323-424-10) > 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

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

Profile 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:

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