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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078032

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NDA 078032 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-seven 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 078032

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

Pharmacology for NDA: 078032

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 078032

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 078032 ANDA SOLCO HEALTHCARE US, LLC 43547-280 43547-280-11 1000 TABLET, FILM COATED in 1 BOTTLE (43547-280-11)
ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 078032 ANDA SOLCO HEALTHCARE US, LLC 43547-280 43547-280-10 100 TABLET, FILM COATED in 1 BOTTLE (43547-280-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Aug 28, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Aug 28, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Aug 28, 2015TE:ABRLD:No


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