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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 077512


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NDA 077512 describes ESCITALOPRAM OXALATE, which is a drug marketed by Norvium Bioscience, Amneal Pharms, Antrim Pharms Llc, Aurobindo Pharma Ltd, Chartwell Molecular, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Taro, Accord Hlthcare, Anima, Chartwell Rx, Dash Pharms, Graviti Pharms, Hikma Pharms, Invagen Pharms, Jubilant Cadista, Prinston Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Lifesciences, and is included in twenty-three NDAs. It is available from fifty 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-one suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
Summary for 077512
Tradename:ESCITALOPRAM OXALATE
Applicant:Anima
Ingredient:escitalopram oxalate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Sep 12, 2012TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Sep 12, 2012TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Sep 12, 2012TE:RLD:No

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