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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203967

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NDA 203967 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-five 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. Fifty-nine suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.

Summary for 203967

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

Pharmacology for NDA: 203967

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 203967

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESCITALOPRAM OXALATE escitalopram oxalate SOLUTION;ORAL 203967 ANDA Leading Pharma, LLC 69315-501 69315-501-24 1 BOTTLE in 1 BOTTLE (69315-501-24) > 240 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 5MG BASE/5ML
Approval Date:May 26, 2015TE:AARLD:No


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Fish and Richardson
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