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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021763

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NDA 021763 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 021763
Tradename:CITALOPRAM HYDROBROMIDE
Applicant:Biovail Labs Intl
Ingredient:citalopram hydrobromide
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021763

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE
Approval Date:Dec 20, 2005TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 20MG BASE
Approval Date:Dec 20, 2005TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 40MG BASE
Approval Date:Dec 20, 2005TE:RLD:No

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Daiichi Sankyo
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Chubb
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Federal Trade Commission
Citi
Baxter
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