Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Accenture
Express Scripts
Cerilliant
Moodys
Julphar
Argus Health
Healthtrust

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076955

« Back to Dashboard

NDA 076955 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 fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the flumazenil profile page.
Summary for 076955
Tradename:FLUMAZENIL
Applicant:Fresenius Kabi Usa
Ingredient:flumazenil
Patents:0
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 N 63323-424-05
FLUMAZENIL flumazenil INJECTABLE;INJECTION 076955 ANDA Fresenius Kabi USA, LLC 63323-424 N 63323-424-10

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Federal Trade Commission
Cipla
Chinese Patent Office
Accenture
AstraZeneca
Queensland Health
Fuji
Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.