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Details for New Drug Application (NDA): 076465

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NDA 076465 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, Roxane, Dr Reddys Labs Ltd, Actavis Elizabeth, Ranbaxy Labs Ltd, Cipla Ltd, Watson Labs, Hikma Pharms, Teva, Torrent Pharms, Lupin, Mylan, Oxford Pharms, Austarpharma Llc, Sun Pharm Inds Ltd, Apotex Inc, Invagen Pharms, and Pliva Hrvatska Doo, and is included in twenty-nine NDAs. It is available from fifty-four 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. There are two tentative approvals for this compound. Additional details are available on the sertraline hydrochloride profile page.

Summary for NDA: 076465

Tradename:
SERTRALINE HYDROCHLORIDE
Applicant:
Teva
Ingredient:
sertraline hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Aug 11, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Aug 11, 2006TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Aug 11, 2006TE:ABRLD:No


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