Last Updated: November 13, 2026

Details for New Drug Application (NDA): 078053

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NDA 078053 describes SERTRALINE HYDROCHLORIDE, which is a drug marketed by Almatica, Amneal, Appco, Novitium Pharma, Umedica, Zenara, Zydus Lifesciences, Aurobindo Pharma, Ranbaxy Labs Ltd, Strides Pharma, Accord Hlthcare, Ascent Pharms Inc, Chartwell Molecular, Granules, Heritage, Heritage Pharma Avet, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Macleods Pharms, Mylan Pharms Inc, Pharmobedient, Quagen, Reyoung, Sciegen Pharms, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Tp Anda Holdings, and Zydus, and is included in thirty-seven NDAs. It is available from fifty-two suppliers. Additional details are available on the SERTRALINE HYDROCHLORIDE profile page.

The generic ingredient in SERTRALINE HYDROCHLORIDE is sertraline hydrochloride. There is one drug master file entry for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.

Summary for 078053

Tradename:	SERTRALINE HYDROCHLORIDE
Applicant:	Ranbaxy Labs Ltd
Ingredient:	sertraline hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 078053

Antidepressive Agents
Serotonin Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CONCENTRATE;ORAL			Strength	EQ 20MG BASE/ML
Approval Date:	Feb 5, 2007	TE:		RLD:	No

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