Details for New Drug Application (NDA): 019839

✉ Email this page to a colleague

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-seven 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DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-004	Dec 30, 1991	5,744,501	⤷ Subscribe
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-001	Dec 30, 1991	5,789,449	⤷ Subscribe
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-003	Dec 30, 1991	4,962,128*PED	⤷ Subscribe
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-004	Dec 30, 1991	4,962,128*PED	⤷ Subscribe
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-004	Dec 30, 1991	5,789,449	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.