Last Updated: June 9, 2026

Details for New Drug Application (NDA): 077043

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NDA 077043 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-eight 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-nine suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.

Summary for 077043

Tradename:	CITALOPRAM HYDROBROMIDE
Applicant:	Hikma
Ingredient:	citalopram hydrobromide
Patents:	0

Pharmacology for NDA: 077043

Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 077043

Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 077043

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CITALOPRAM HYDROBROMIDE	citalopram hydrobromide	SOLUTION;ORAL	077043	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0062	0054-0062-58	1 BOTTLE, PLASTIC in 1 CARTON (0054-0062-58) / 240 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 10MG BASE/5ML
Approval Date:	Dec 13, 2004	TE:	AA	RLD:	No

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