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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 078175

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NDA 078175 describes SERTRALINE HYDROCHLORIDE, which is a drug marketed by Almatica, Zenara, Aurobindo Pharma, Ranbaxy Labs Ltd, Strides Pharma, Accord Hlthcare, Appco, Ascent Pharms Inc, Chartwell Molecular, Granules, Heritage Pharma Avet, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan Pharms Inc, Oxford Pharms, Pharmaco, Pharmobedient, Quagen, Reyoung, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Tp Anda Holdings, and Zydus, and is included in thirty-two NDAs. It is available from forty-one 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. Forty-four suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.

Summary for 078175

Tradename:	SERTRALINE HYDROCHLORIDE
Applicant:	Oxford Pharms
Ingredient:	sertraline hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 078175

Antidepressive Agents
Serotonin Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Jul 21, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Jul 21, 2010	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Jul 21, 2010	TE:	AB	RLD:	No

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