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Argus Health
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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077734

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NDA 077734 describes ESCITALOPRAM OXALATE, which is a drug marketed by Mylan Pharms Inc, Amneal Pharms, Antrim Pharms Llc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Silarx Pharms Inc, 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 fifty-nine 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-three suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
Summary for 077734
Tradename:ESCITALOPRAM OXALATE
Applicant:Zydus Pharms Usa Inc
Ingredient:escitalopram oxalate
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Pharmacology for NDA: 077734
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 077734
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 077734 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-102 N 68382-102-01
ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 077734 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-102 N 68382-102-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Sep 11, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Sep 11, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Sep 11, 2012TE:ABRLD:No

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