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Serving 500+ biopharmaceutical companies globally:

US Army
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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078053

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NDA 078053 describes SERTRALINE HYDROCHLORIDE, which is a drug marketed by Wockhardt, Aurobindo Pharma, Zydus Pharms Usa, Sun Pharm Inds (in), Sandoz, Frontida Biopharm, Ivax Sub Teva Pharms, Accord Hlthcare, Mylan Pharms Inc, Allied Pharma Inc, Dr Reddys Labs Ltd, Actavis Elizabeth, Ranbaxy Labs Ltd, Cipla Ltd, Watson Labs Teva, Hikma Pharms, Teva, Torrent Pharms, Lupin, Mylan, Oxford Pharms, Austarpharma Llc, Sun Pharm Inds Ltd, Aci Healthcare Ltd, Apotex Inc, Invagen Pharms, and Pliva Hrvatska Doo, and is included in twenty-nine NDAs. It is available from fifty-three suppliers. Additional details are available on the SERTRALINE HYDROCHLORIDE profile page.

The generic ingredient in SERTRALINE HYDROCHLORIDE is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.

Summary for NDA: 078053

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CONCENTRATE;ORALStrengthEQ 20MG BASE/ML
Approval Date:Feb 5, 2007TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Moodys
Federal Trade Commission
McKinsey
Cerilliant
Argus Health
Colorcon
Farmers Insurance
US Department of Justice
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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