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Generated: October 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078289

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NDA 078289 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 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. Twelve suppliers are listed for this compound. Additional details are available on the etomidate profile page.
Summary for 078289
Tradename:ETOMIDATE
Applicant:Mylan Labs Ltd
Ingredient:etomidate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078289
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 078289
Suppliers and Packaging for NDA: 078289
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETOMIDATE etomidate INJECTABLE;INJECTION 078289 ANDA Sagent Pharmaceuticals 25021-674 25021-674-10 10 VIAL in 1 CARTON (25021-674-10) > 10 mL in 1 VIAL
ETOMIDATE etomidate INJECTABLE;INJECTION 078289 ANDA Sagent Pharmaceuticals 25021-674 25021-674-20 10 VIAL in 1 CARTON (25021-674-20) > 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Jan 2, 2009TE:APRLD:No

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