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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078626

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NDA 078626 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, Chartwell Molecular, Fosun Pharma, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Mylan Pharms Inc, Oxford Pharms, Pliva Hrvatska Doo, Sciegen Pharms Inc, 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-seven 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-two suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
Summary for 078626
Tradename:SERTRALINE HYDROCHLORIDE
Applicant:Mylan Pharms Inc
Ingredient:sertraline hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078626
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 078626
Suppliers and Packaging for NDA: 078626
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 078626 ANDA Mylan Pharmaceuticals Inc. 0378-8011 N 0378-8011-01
SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 078626 ANDA Mylan Pharmaceuticals Inc. 0378-8011 N 0378-8011-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Jan 31, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Jan 31, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Jan 31, 2008TE:ABRLD:No

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