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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 202221

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NDA 202221 describes ESCITALOPRAM OXALATE, which is a drug marketed by Rising, Amneal Pharms, Antrim Pharms Llc, Aurobindo Pharma Ltd, Chartwell Molecular, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Sun Pharma Canada, Accord Hlthcare, Aiping Pharm Inc, Ascent Pharms Inc, Chartwell Rx, Graviti Pharms, Hikma Pharms, Invagen Pharms, Jubilant Cadista, Novitium Pharma, Prinston Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Lifesciences, and is included in twenty-four NDAs. It is available from forty-three 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. Forty-five suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.

Summary for 202221

Tradename:	ESCITALOPRAM OXALATE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	escitalopram oxalate
Patents:	0

Pharmacology for NDA: 202221

Mechanism of Action	Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 202221

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESCITALOPRAM OXALATE	escitalopram oxalate	SOLUTION;ORAL	202221	ANDA	Camber Pharmaceuticals, Inc.	31722-569	31722-569-24	240 mL in 1 BOTTLE (31722-569-24)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 5MG BASE/5ML
Approval Date:	Jun 12, 2012	TE:	AA	RLD:	No

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