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Serving 500+ biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo
Express Scripts
Chinese Patent Office
Boehringer Ingelheim

Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078867

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NDA 078867 describes ETOMIDATE, which is a drug marketed by Emcure Pharms Ltd, Aurobindo Pharma Ltd, Mylan Labs Ltd, Hikma Farmaceutica, Gland Pharma Ltd, Zydus Pharms Usa Inc, Luitpold, West-ward Pharms Int, and Par Sterile Products, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the ETOMIDATE profile page.

The generic ingredient in ETOMIDATE is etomidate. There are six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the etomidate profile page.

Summary for NDA: 078867

Formulation / Manufacturing:see details

Pharmacology for NDA: 078867

Physiological EffectGeneral Anesthesia

Suppliers and Packaging for NDA: 078867

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 078867 ANDA American Regent, Inc. 0517-0780 0517-0780-10 10 VIAL, GLASS in 1 CARTON (0517-0780-10) > 10 mL in 1 VIAL, GLASS (0517-0780-01)
INJECTABLE;INJECTION 078867 ANDA American Regent, Inc. 0517-0781 0517-0781-10 10 VIAL, GLASS in 1 CARTON (0517-0781-10) > 20 mL in 1 VIAL, GLASS (0517-0781-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Dec 22, 2009TE:APRLD:No

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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
US Department of Justice
Daiichi Sankyo
Johnson and Johnson
Federal Trade Commission

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