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Serving leading biopharmaceutical companies globally:

Colorcon
Deloitte
McKinsey
Argus Health
Chinese Patent Office
Citi
Medtronic
US Army
Teva
Farmers Insurance

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202825

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NDA 202825 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-five 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-one suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.

Summary for 202825

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

Pharmacology for NDA: 202825

Mechanism of ActionSerotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 202825

Suppliers and Packaging for NDA: 202825

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 202825 ANDA Accord Healthcare, Inc. 16729-215 16729-215-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-215-10)
SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 202825 ANDA Accord Healthcare, Inc. 16729-216 16729-216-15 90 TABLET, FILM COATED in 1 BOTTLE (16729-216-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Nov 7, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Nov 7, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Nov 7, 2014TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Merck
Deloitte
Dow
Farmers Insurance
Harvard Business School
Medtronic
Colorcon
Fish and Richardson
QuintilesIMS
Baxter

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