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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 219130

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NDA 219130 describes ESCITALOPRAM, which is a drug marketed by Almatica, 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-five NDAs. It is available from one supplier. Additional details are available on the ESCITALOPRAM profile page.

The generic ingredient in ESCITALOPRAM 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 219130

Tradename:	ESCITALOPRAM
Applicant:	Almatica
Ingredient:	escitalopram oxalate
Patents:	0

Pharmacology for NDA: 219130

Mechanism of Action	Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 219130

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESCITALOPRAM	escitalopram oxalate	CAPSULE;ORAL	219130	NDA	Almatica Pharma LLC	52427-795	52427-795-30	30 CAPSULE in 1 BOTTLE (52427-795-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 15MG BASE
Approval Date:	Aug 29, 2025	TE:		RLD:	Yes

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