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Fish and Richardson
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077812

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NDA 077812 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, 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-eight 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-nine suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.
Summary for 077812
Tradename:CITALOPRAM HYDROBROMIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:citalopram hydrobromide
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 077812
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 077812
Suppliers and Packaging for NDA: 077812
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CITALOPRAM HYDROBROMIDE citalopram hydrobromide SOLUTION;ORAL 077812 ANDA Citron Pharma LLC 57237-148 N 57237-148-24
CITALOPRAM HYDROBROMIDE citalopram hydrobromide SOLUTION;ORAL 077812 ANDA Aurobindo Pharma Limited 65862-074 N 65862-074-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 10MG BASE/5ML
Approval Date:Aug 28, 2006TE:AARLD:No

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