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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 219655

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NDA 219655 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 219655

Tradename:	SERTRALINE HYDROCHLORIDE
Applicant:	Skg Pharma
Ingredient:	sertraline hydrochloride
Patents:	0

Pharmacology for NDA: 219655

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 219655

Antidepressive Agents
Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 219655

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	CAPSULE;ORAL	219655	ANDA	Amneal Pharmaceuticals NY LLC	69238-2789	69238-2789-1	30 CAPSULE in 1 BOTTLE (69238-2789-1)
SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	CAPSULE;ORAL	219655	ANDA	Amneal Pharmaceuticals NY LLC	69238-2791	69238-2791-1	30 CAPSULE in 1 BOTTLE (69238-2791-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Jan 28, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Jan 28, 2026	TE:	AB	RLD:	No

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