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Serving leading biopharmaceutical companies globally:

Healthtrust
Accenture
US Army
McKinsey
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AstraZeneca
Medtronic
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Cerilliant

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078604

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NDA 078604 describes ESCITALOPRAM OXALATE, which is a drug marketed by Invagen Pharms, Macleods Pharms Ltd, Sti Pharma Llc, Amneal Pharms, Hetero Labs Ltd Iii, Taro, Aurobindo Pharma Ltd, Prinston Inc, Zydus Pharms Usa Inc, Torrent Pharms Ltd, Mylan Pharms Inc, Teva Pharms Usa, Hikma Pharms, Antrim Pharms Llc, Lupin Ltd, Silarx Pharms Inc, Apotex Inc, Jubilant Generics, and Accord Hlthcare, and is included in twenty-three NDAs. It is available from fifty-six 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-one suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.

Summary for NDA: 078604

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics

Pharmacology for NDA: 078604

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 078604

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESCITALOPRAM OXALATE
escitalopram oxalate
TABLET;ORAL 078604 ANDA Camber Pharmaceuticals 31722-249 31722-249-01 100 TABLET in 1 BOTTLE (31722-249-01)
ESCITALOPRAM OXALATE
escitalopram oxalate
TABLET;ORAL 078604 ANDA Camber Pharmaceuticals 31722-249 31722-249-05 500 TABLET in 1 BOTTLE (31722-249-05)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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QuintilesIMS
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