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Last Updated: July 6, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019839


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NDA 019839 describes ZOLOFT, which is a drug marketed by Pfizer and is included in two NDAs. It is available from five suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
Summary for 019839
Tradename:ZOLOFT
Applicant:Pfizer
Ingredient:sertraline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019839
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 019839
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
Paragraph IV (Patent) Challenges for 019839
Tradename Dosage Ingredient NDA Submissiondate
ZOLOFT TABLET;ORAL sertraline hydrochloride 019839 2005-11-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Dec 30, 1991TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Dec 30, 1991TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 30, 1991TE:RLD:Yes

Expired US Patents for NDA 019839

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-004 Dec 30, 1991   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-003 Dec 30, 1991   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-001 Dec 30, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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