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Last Updated: August 11, 2020

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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 Mylan Pharms Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Hikma, Lannett Co Inc, Pharm Assoc, Biovail Labs Intl, Amneal Pharms Ny, Apotex Inc, Aurobindo, Chartwell Molecular, Cosette, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Fosun Pharma, Glenmark Generics, Heritage Pharma, Invagen Pharms, Jubilant Generics, Mylan, Natco Pharma Ltd, Roxane, Sun Pharm Inds Inc, Sun Pharm Industries, Taro, Torpharm, and Torrent Pharms, and is included in thirty-three NDAs. It is available from forty-four 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. Forty-five suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.
Summary for 077032
Tradename:CITALOPRAM HYDROBROMIDE
Applicant:Sun Pharm Inds Inc
Ingredient:citalopram hydrobromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077032
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 077032
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 Sun Pharmaceutical Industries, Inc. 57664-507 57664-507-13 500 TABLET in 1 BOTTLE (57664-507-13)
CITALOPRAM HYDROBROMIDE citalopram hydrobromide TABLET;ORAL 077032 ANDA Sun Pharmaceutical Industries, Inc. 57664-507 57664-507-88 100 TABLET in 1 BOTTLE (57664-507-88)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Nov 12, 2004TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Nov 12, 2004TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Nov 12, 2004TE:RLD:No

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