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Mallinckrodt
Dow
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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077977

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NDA 077977 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-eight 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-three suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
Summary for 077977
Tradename:SERTRALINE HYDROCHLORIDE
Applicant:Sun Pharm Inds Ltd
Ingredient:sertraline hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details
Pharmacology for NDA: 077977
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 077977
Suppliers and Packaging for NDA: 077977
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077977 ANDA Ranbaxy Pharmaceuticals Inc. 63304-164 N 63304-164-03
SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077977 ANDA Ranbaxy Pharmaceuticals Inc. 63304-164 N 63304-164-30

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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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
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Daiichi Sankyo
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Federal Trade Commission
Fuji
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Deloitte
Boehringer Ingelheim

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