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Generated: July 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077048

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NDA 077048 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: 077048

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

Pharmacology for NDA: 077048

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 077048

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CITALOPRAM HYDROBROMIDE
citalopram hydrobromide
TABLET;ORAL 077048 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6510 0615-6510-31 31 TABLET in 1 BLISTER PACK (0615-6510-31)
CITALOPRAM HYDROBROMIDE
citalopram hydrobromide
TABLET;ORAL 077048 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6510 0615-6510-39 30 TABLET in 1 BLISTER PACK (0615-6510-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Nov 16, 2004TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Nov 16, 2004TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Nov 16, 2004TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

McKesson
Julphar
Johnson and Johnson
US Department of Justice
Cipla
Cantor Fitzgerald
Harvard Business School
Federal Trade Commission
UBS
Citi

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