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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078216


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NDA 078216 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, Acp Nimble, Amneal Pharms Ny, Apotex Inc, Aurobindo, Chartwell Molecular, 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 078216
Tradename:CITALOPRAM HYDROBROMIDE
Applicant:Torrent Pharms
Ingredient:citalopram hydrobromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078216
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 078216
Suppliers and Packaging for NDA: 078216
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CITALOPRAM HYDROBROMIDE citalopram hydrobromide TABLET;ORAL 078216 ANDA Major Pharmaceuticals 0904-6084 0904-6084-61 100 BLISTER PACK in 1 CARTON (0904-6084-61) > 1 TABLET in 1 BLISTER PACK
CITALOPRAM HYDROBROMIDE citalopram hydrobromide TABLET;ORAL 078216 ANDA Major Pharmaceuticals 0904-6085 0904-6085-61 100 BLISTER PACK in 1 CARTON (0904-6085-61) > 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Mar 27, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Mar 27, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Mar 27, 2007TE:ABRLD:No

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