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Serving 500+ biopharmaceutical companies globally:

Accenture
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Express Scripts
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Fuji
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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077765

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NDA 077765 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: 077765

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

Pharmacology for NDA: 077765

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 077765

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL 077765 ANDA Torrent Pharmaceuticals Limited 13668-004 13668-004-01 100 TABLET, FILM COATED in 1 BOTTLE (13668-004-01)
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL 077765 ANDA Torrent Pharmaceuticals Limited 13668-004 13668-004-05 500 TABLET, FILM COATED in 1 BOTTLE (13668-004-05)

Summary for product number 001

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

Summary for product number 002

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

Summary 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 500+ biopharmaceutical companies globally:

Merck
Fuji
AstraZeneca
Baxter
Colorcon
McKesson
Boehringer Ingelheim
Cerilliant
Julphar
Cipla

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