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Harvard Business School
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Generated: December 10, 2017

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, 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-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:1
Applicant:1
Ingredient:1
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 57237-148-24 240 mL in 1 BOTTLE (57237-148-24)
CITALOPRAM HYDROBROMIDE citalopram hydrobromide SOLUTION;ORAL 077812 ANDA Aurobindo Pharma Limited 65862-074 65862-074-24 240 mL in 1 BOTTLE (65862-074-24)

Summary 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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Serving leading biopharmaceutical companies globally:

Baxter
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Cipla
US Army
Boehringer Ingelheim
UBS
Colorcon
Daiichi Sankyo
Harvard Business School
Chinese Patent Office

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