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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chubb
Fish and Richardson
Teva
Healthtrust
Federal Trade Commission
McKinsey
US Department of Justice
Citi
Cerilliant

Generated: January 16, 2018

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 Mylan Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Silarx, West-ward Pharms Int, Biovail Labs Intl, Actavis Elizabeth, Amneal Pharms Ny, Aurobindo, Cipla Ltd, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, G And W Labs Inc, Glenmark Generics, Invagen Pharms, Jubilant Generics, Mylan, Natco Pharma Ltd, Pliva, Roxane, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Taro, Teva Pharms, Torpharm, Torrent Pharms, and Watson Labs, and is included in thirty-three NDAs. It is available from sixty-nine 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. Seventy suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.
Summary for 077048
Tradename:CITALOPRAM HYDROBROMIDE
Applicant:G And W Labs Inc
Ingredient:citalopram hydrobromide
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 077048
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 077048
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)

Profile for product number 001

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

Profile for product number 002

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

Profile 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 leading biopharmaceutical companies globally:

Deloitte
Boehringer Ingelheim
Fuji
Express Scripts
Chinese Patent Office
Mallinckrodt
Dow
US Department of Justice
Cipla

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