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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077206

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NDA 077206 describes SERTRALINE HYDROCHLORIDE, which is a drug marketed by Allied Pharma Inc, Aurobindo Pharma, Ranbaxy Labs Ltd, Accord Hlthcare, Aci Healthcare Ltd, Actavis Elizabeth, Anda Repository, Apotex Inc, Austarpharma Llc, Cipla Ltd, Dr Reddys Labs Ltd, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Mylan Pharms Inc, Oxford Pharms, Pliva Hrvatska Doo, Sandoz, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Torrent Pharms, Watson Labs Teva, Wockhardt, and Zydus Pharms Usa, and is included in twenty-nine NDAs. It is available from fifty-nine 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-five suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
Summary for 077206
Tradename:SERTRALINE HYDROCHLORIDE
Applicant:Aurobindo Pharma
Ingredient:sertraline hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details
Pharmacology for NDA: 077206
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 077206
Suppliers and Packaging for NDA: 077206
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077206 ANDA Aurolife Pharma LLC 13107-011 13107-011-90 90 TABLET in 1 BOTTLE (13107-011-90)
SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077206 ANDA Aurolife Pharma LLC 13107-011 13107-011-30 30 TABLET in 1 BOTTLE (13107-011-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Feb 6, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Feb 6, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Feb 6, 2007TE:ABRLD:No

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Boehringer Ingelheim
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Merck
McKesson
Teva
Chubb
Novartis
US Department of Justice
Fuji

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