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McKinsey
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Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091297

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NDA 091297 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 eleven 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 091297

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 091297

Physiological EffectGeneral Anesthesia

Medical Subject Heading (MeSH) Categories for 091297

Suppliers and Packaging for NDA: 091297

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETOMIDATE
etomidate
INJECTABLE;INJECTION 091297 ANDA Mylan Institutional LLC 67457-183 67457-183-10 10 VIAL, SINGLE-USE in 1 CARTON (67457-183-10) > 10 mL in 1 VIAL, SINGLE-USE (67457-183-00)
ETOMIDATE
etomidate
INJECTABLE;INJECTION 091297 ANDA Mylan Institutional LLC 67457-183 67457-183-20 10 VIAL, SINGLE-USE in 1 CARTON (67457-183-20) > 20 mL in 1 VIAL, SINGLE-USE (67457-183-99)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Jun 20, 2012TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Chubb
US Army
US Department of Justice
Federal Trade Commission
AstraZeneca
Daiichi Sankyo
Teva
Deloitte
Colorcon
Novartis

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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