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Serving 500+ biopharmaceutical companies globally:

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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077864

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NDA 077864 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: 077864

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

Pharmacology for NDA: 077864

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 077864

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL 077864 ANDA West-ward Pharmaceutical Corp 0143-9580 0143-9580-05 500 TABLET, FILM COATED in 1 BOTTLE (0143-9580-05)
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL 077864 ANDA West-ward Pharmaceutical Corp 0143-9580 0143-9580-09 90 TABLET, FILM COATED in 1 BOTTLE (0143-9580-09)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Aug 10, 2009TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Aug 10, 2009TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Aug 10, 2009TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Express Scripts
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Harvard Business School
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Dow
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