Last Updated: May 3, 2026

Details for New Drug Application (NDA): 219985

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NDA 219985 describes CITALOPRAM HYDROBROMIDE, which is a drug marketed by Almatica, Aurobindo Pharma Ltd, Pharmobedient, Aurobindo Pharma, Chartwell Molecular, Hetero Labs Ltd Iii, Hikma, Pharm Assoc, Biovail Labs Intl, Amneal Pharms Ny, Apotex, Aurobindo, Chartwell Rx, Cosette, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Fosun Pharma, Glenmark Pharms Ltd, Heritage Pharma, Invagen Pharms, Jubilant Generics, Mylan, Natco Pharma Ltd, Roxane, Sun Pharm Inds Inc, Sun Pharm Industries, Taro, and Torrent Pharms, and is included in thirty-five NDAs. It is available from thirty-six suppliers. Additional details are available on the CITALOPRAM HYDROBROMIDE profile page.

The generic ingredient in CITALOPRAM HYDROBROMIDE is citalopram hydrobromide. There are fifty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.

Summary for 219985

Tradename:	CITALOPRAM HYDROBROMIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	citalopram hydrobromide
Patents:	0

Pharmacology for NDA: 219985

Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 219985

Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 219985

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CITALOPRAM HYDROBROMIDE	citalopram hydrobromide	CAPSULE;ORAL	219985	ANDA	Aurobindo Pharma Limited	59651-964	59651-964-30	30 CAPSULE in 1 BOTTLE (59651-964-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 30MG BASE
Approval Date:	Mar 13, 2026	TE:	AB	RLD:	No
Regulatory Exclusivity Expiration:	Sep 16, 2026
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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