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Details for New Drug Application (NDA): 202210

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NDA 202210 describes ESCITALOPRAM OXALATE, which is a drug marketed by Invagen Pharms, Macleods Pharms Ltd, Sti Pharma Llc, Hetero Labs Ltd Iii, Taro, Amneal Pharms, Aurobindo Pharma Ltd, Prinston Inc, Zydus Pharms Usa Inc, Torrent Pharms Ltd, Mylan Pharms Inc, Teva Pharms Usa, Hikma Pharms, Antrim Pharms Llc, Lupin Ltd, Silarx Pharms Inc, Apotex Inc, Jubilant Generics, and Accord Hlthcare, and is included in twenty-two NDAs. It is available from fifty-three suppliers. Additional details are available on the ESCITALOPRAM OXALATE profile page.

The generic ingredient in ESCITALOPRAM OXALATE is escitalopram oxalate. There are twenty-five drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. There are eighteen tentative approvals for this compound. Additional details are available on the escitalopram oxalate profile page.

Summary for NDA: 202210

Tradename:
ESCITALOPRAM OXALATE
Applicant:
Macleods Pharms Ltd
Ingredient:
escitalopram oxalate
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics

Pharmacology for NDA: 202210

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 202210

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESCITALOPRAM OXALATE
escitalopram oxalate
TABLET;ORAL 202210 ANDA Macleods Pharmaceuticals Limited 33342-036 33342-036-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-036-11)
ESCITALOPRAM OXALATE
escitalopram oxalate
TABLET;ORAL 202210 ANDA Macleods Pharmaceuticals Limited 33342-036 33342-036-12 100 TABLET, FILM COATED in 1 CARTON (33342-036-12)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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