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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Moodys
Citi
Fuji
Express Scripts
US Army
Cantor Fitzgerald
Johnson and Johnson
Mallinckrodt

Generated: April 26, 2018

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 eleven 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. Sixty-three 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
Therapeutic Class:Antidepressants
Anxiolytics
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 N 0049-4900-30
ZOLOFT sertraline hydrochloride TABLET;ORAL 019839 NDA Roerig 0049-4900 N 0049-4900-41

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150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 ➤ Sign Up ➤ Sign Up
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-004 Dec 30, 1991 ➤ Sign Up ➤ Sign Up
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-001 Dec 30, 1991 ➤ Sign Up ➤ Sign Up
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-001 Dec 30, 1991 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Covington
Harvard Business School
UBS
Cerilliant
US Department of Justice
Moodys
Baxter
Boehringer Ingelheim

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