Details for New Drug Application (NDA): 078677

NDA 078677 describes SERTRALINE HYDROCHLORIDE, which is a drug marketed by Almatica, Aurobindo Pharma, Ranbaxy Labs Ltd, Strides Pharma, Accord Hlthcare, Anda Repository, Appco, Ascent Pharms Inc, Chartwell Molecular, Granules, Heritage Pharma Avet, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan Pharms Inc, Norvium Bioscience, Oxford Pharms, Reyoung, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Viwit Pharm, and Zydus, and is included in thirty-one NDAs. It is available from forty-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. Forty-seven suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.

Summary for 078677

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

Medical Subject Heading (MeSH) Categories for 078677

Antidepressive Agents

Serotonin Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Mar 4, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Mar 4, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Mar 4, 2009	TE:	AB	RLD:	No

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