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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077289

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NDA 077289 describes CITALOPRAM HYDROBROMIDE, which is a drug marketed by Mylan Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Lannett Co Inc, West-ward Pharms Int, Biovail Labs Intl, Actavis Elizabeth, Amneal Pharms Ny, Aurobindo, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Fosun Pharma, G And W Labs Inc, Glenmark Generics, Invagen Pharms, Jubilant Generics, Mylan, Natco Pharma Ltd, Pliva, Roxane, 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-seven 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. Sixty-eight suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.
Summary for 077289
Tradename:CITALOPRAM HYDROBROMIDE
Applicant:Amneal Pharms Ny
Ingredient:citalopram hydrobromide
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 077289
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 077289
Suppliers and Packaging for NDA: 077289
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CITALOPRAM HYDROBROMIDE citalopram hydrobromide TABLET;ORAL 077289 ANDA PD-Rx Pharmaceuticals, Inc. 43063-063 N 43063-063-14
CITALOPRAM HYDROBROMIDE citalopram hydrobromide TABLET;ORAL 077289 ANDA PD-Rx Pharmaceuticals, Inc. 43063-063 N 43063-063-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Nov 30, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Nov 30, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Nov 30, 2006TE:ABRLD:No

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