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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 078403

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NDA 078403 describes SERTRALINE HYDROCHLORIDE, which is a drug marketed by Almatica, Appco, Novitium Pharma, Skg 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, Mylan Pharms Inc, Oxford Pharms, Pharmaco, 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 forty-eight 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. Fifty-one suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.

Summary for 078403

Tradename:	SERTRALINE HYDROCHLORIDE
Applicant:	Granules
Ingredient:	sertraline hydrochloride
Patents:	0

Pharmacology for NDA: 078403

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 078403

Antidepressive Agents
Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 078403

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	TABLET;ORAL	078403	ANDA	A-S Medication Solutions	50090-7395	50090-7395-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-7395-0)
SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	TABLET;ORAL	078403	ANDA	A-S Medication Solutions	50090-7395	50090-7395-1	90 TABLET, FILM COATED in 1 BOTTLE (50090-7395-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Jan 8, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Jan 8, 2008	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Jan 8, 2008	TE:	AB	RLD:	No

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