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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078604


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NDA 078604 describes ESCITALOPRAM OXALATE, which is a drug marketed by Mylan Pharms Inc, Amneal Pharms, Antrim Pharms Llc, Aurobindo Pharma Ltd, Chartwell Molecular, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Taro, Accord Hlthcare, Dash Pharms, Graviti Pharms, Hikma Pharms, Invagen Pharms, Jubilant Cadista, Lupin Ltd, Pharm Assoc, 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 078604
Tradename:ESCITALOPRAM OXALATE
Applicant:Invagen Pharms
Ingredient:escitalopram oxalate
Patents:0
Formulation / Manufacturing:see details
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 Legacy Pharmaceutical Packaging, LLC 68645-519 68645-519-54 30 TABLET, FILM COATED in 1 BOTTLE (68645-519-54)
ESCITALOPRAM OXALATE escitalopram oxalate TABLET;ORAL 078604 ANDA Legacy Pharmaceutical Packaging, LLC 68645-520 68645-520-54 30 TABLET, FILM COATED in 1 BOTTLE (68645-520-54)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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