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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Healthtrust
Farmers Insurance
Cipla
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Cerilliant
Medtronic
Chinese Patent Office
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Generated: June 29, 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 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 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 NDA: 078595

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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
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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Serving 500+ biopharmaceutical companies globally:

Cipla
Chubb
US Army
Teva
Colorcon
Johnson and Johnson
Dow
Medtronic
Cerilliant
Boehringer Ingelheim

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.

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