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Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078867

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NDA 078867 describes ETOMIDATE, which is a drug marketed by Aurobindo Pharma Ltd, Emcure Pharms Ltd, Gland Pharma Ltd, Hikma Farmaceutica, Luitpold, Mylan Labs Ltd, Par Sterile Products, West-ward Pharms Int, and Zydus Pharms Usa Inc, and is included in ten NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the etomidate profile page.
Summary for 078867
Formulation / Manufacturing:see details
Pharmacology for NDA: 078867
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 078867
Suppliers and Packaging for NDA: 078867
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETOMIDATE etomidate INJECTABLE;INJECTION 078867 ANDA American Regent, Inc. 0517-0780 N 0517-0780-10
ETOMIDATE etomidate INJECTABLE;INJECTION 078867 ANDA American Regent, Inc. 0517-0781 N 0517-0781-10

Profile for product number 001

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

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Daiichi Sankyo
Federal Trade Commission
Fish and Richardson

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