Details for New Drug Application (NDA): 021763

NDA 021763 describes CITALOPRAM HYDROBROMIDE, which is a drug marketed by Almatica, Norvium Bioscience, 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-four NDAs. It is available from forty-three 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. Forty-four suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.

Summary for 021763

Tradename:	CITALOPRAM HYDROBROMIDE
Applicant:	Biovail Labs Intl
Ingredient:	citalopram hydrobromide
Patents:	0

Medical Subject Heading (MeSH) Categories for 021763

Antidepressive Agents, Second-Generation

Serotonin Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 10MG BASE
Approval Date:	Dec 20, 2005	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 20MG BASE
Approval Date:	Dec 20, 2005	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 40MG BASE
Approval Date:	Dec 20, 2005	TE:		RLD:	Yes

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