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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Colorcon
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Queensland Health
US Department of Justice
Julphar
Cantor Fitzgerald
Medtronic

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076765

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NDA 076765 describes ESCITALOPRAM OXALATE, which is a drug marketed by Mylan Pharms Inc, Amneal Pharms, Antrim Pharms Llc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Lannett Co Inc, Macleods Pharms Ltd, Taro, Accord Hlthcare, Apotex Inc, Hikma Pharms, Invagen Pharms, Jubilant Generics, Lupin Ltd, Prinston Inc, Sti Pharma Llc, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in twenty-three NDAs. It is available from sixty-one suppliers. Additional details are available on the ESCITALOPRAM OXALATE profile page.

The generic ingredient in ESCITALOPRAM OXALATE is escitalopram oxalate. There are twenty-six drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
Summary for 076765
Tradename:ESCITALOPRAM OXALATE
Applicant:Teva Pharms Usa
Ingredient:escitalopram oxalate
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Pharmacology for NDA: 076765
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 076765
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 076765 ANDA Teva Pharmaceuticals USA, Inc. 0093-5850 N 0093-5850-01
ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 076765 ANDA Teva Pharmaceuticals USA, Inc. 0093-5850 N 0093-5850-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Mar 14, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Mar 14, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Mar 14, 2012TE:ABRLD:No

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Boehringer Ingelheim
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Chubb
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