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Generated: September 20, 2017

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Details for New Drug Application (NDA): 077032

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NDA 077032 describes CITALOPRAM HYDROBROMIDE, which is a drug marketed by Apotex Inc, Jubilant Generics, Aurobindo Pharma Ltd, Teva Pharms, Torrent Pharms, Silarx, Aurobindo, Pliva, Sun Pharm Inds Inc, Actavis Elizabeth, Invagen Pharms, Watson Labs, Sandoz, Epic Pharma Llc, Mylan Pharms Inc, Dr Reddys Labs Ltd, Mylan, Natco Pharma Ltd, Roxane, West-ward Pharms Int, Cipla Ltd, Epic Pharma, Torpharm, G And W Labs Inc, Hetero Labs Ltd Iii, Sun Pharm Inds, Glenmark Generics, Biovail Labs Intl, Taro, and Amneal Pharms Ny, and is included in thirty-three NDAs. It is available from sixty-seven suppliers. Additional details are available on the CITALOPRAM HYDROBROMIDE profile page.

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

Summary for NDA: 077032

Tradename:	1
Applicant:	1
Ingredient:	1
Patents:	0
Therapeutic Class:	Antidepressants
Formulation / Manufacturing:	see details

Pharmacology for NDA: 077032

Mechanism of Action	Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 077032

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CITALOPRAM HYDROBROMIDE	citalopram hydrobromide	TABLET;ORAL	077032	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-221	43063-221-01	100 TABLET in 1 BOTTLE, PLASTIC (43063-221-01)
CITALOPRAM HYDROBROMIDE	citalopram hydrobromide	TABLET;ORAL	077032	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-221	43063-221-30	30 TABLET in 1 BOTTLE, PLASTIC (43063-221-30)

Summary for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Nov 12, 2004	TE:	AB	RLD:	No

Summary for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Nov 12, 2004	TE:	AB	RLD:	No

Summary for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE
Approval Date:	Nov 12, 2004	TE:	AB	RLD:	No

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