Details for New Drug Application (NDA): 020990

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NDA 020990 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 020990

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

Pharmacology for NDA: 020990

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 020990

Antidepressive Agents
Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 020990

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLOFT	sertraline hydrochloride	CONCENTRATE;ORAL	020990	NDA	ROERIG	0049-0050	0049-0050-01	1 BOTTLE, DROPPER in 1 CARTON (0049-0050-01) / 60 mL in 1 BOTTLE, DROPPER
ZOLOFT	sertraline hydrochloride	CONCENTRATE;ORAL	020990	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-0067	59762-0067-1	60 mL in 1 BOTTLE, DROPPER (59762-0067-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CONCENTRATE;ORAL			Strength	EQ 20MG BASE/ML
Approval Date:	Dec 7, 1999	TE:	AA	RLD:	Yes

Expired US Patents for NDA 020990

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	ZOLOFT	sertraline hydrochloride	CONCENTRATE;ORAL	020990-001	Dec 7, 1999	⤷ Sign Up	⤷ Sign Up
Viatris	ZOLOFT	sertraline hydrochloride	CONCENTRATE;ORAL	020990-001	Dec 7, 1999	⤷ Sign Up	⤷ Sign Up
Viatris	ZOLOFT	sertraline hydrochloride	CONCENTRATE;ORAL	020990-001	Dec 7, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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