Details for New Drug Application (NDA): 019839

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NDA 019839 describes ZOLOFT, which is a drug marketed by Viatris and is included in two NDAs. It is available from four suppliers. Additional details are available on the ZOLOFT profile page.

The generic ingredient in ZOLOFT is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.

Summary for 019839

Tradename:	ZOLOFT
Applicant:	Viatris
Ingredient:	sertraline hydrochloride
Patents:	0

Pharmacology for NDA: 019839

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 019839

Antidepressive Agents
Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 019839

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839	NDA	ROERIG	0049-4900	0049-4900-30	30 TABLET, FILM COATED in 1 BOTTLE (0049-4900-30)
ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839	NDA	ROERIG	0049-4900	0049-4900-41	100 BLISTER PACK in 1 CARTON (0049-4900-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Dec 30, 1991	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Dec 30, 1991	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 30, 1991	TE:		RLD:	Yes

Expired US Patents for NDA 019839

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-003	Dec 30, 1991	⤷ Sign Up	⤷ Sign Up
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-002	Dec 30, 1991	⤷ Sign Up	⤷ Sign Up
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-002	Dec 30, 1991	⤷ Sign Up	⤷ Sign Up
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-005	Mar 6, 1996	⤷ Sign Up	⤷ Sign Up
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-004	Dec 30, 1991	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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