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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Dow
Federal Trade Commission
Teva
Baxter
Julphar
Merck
UBS
Colorcon

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079062

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NDA 079062 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-eight 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-two suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
Summary for 079062
Tradename:ESCITALOPRAM OXALATE
Applicant:Aurobindo Pharma Ltd
Ingredient:escitalopram oxalate
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Pharmacology for NDA: 079062
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 079062
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESCITALOPRAM OXALATE escitalopram oxalate SOLUTION;ORAL 079062 ANDA Citron Pharma LLC 57237-095 N 57237-095-24
ESCITALOPRAM OXALATE escitalopram oxalate SOLUTION;ORAL 079062 ANDA Aurobindo Pharma Limited 65862-248 N 65862-248-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 5MG BASE/5ML
Approval Date:Apr 2, 2012TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Accenture
Johnson and Johnson
Queensland Health
Fish and Richardson
Colorcon
Dow
Mallinckrodt
Fuji

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