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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 204516


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NDA 204516 describes BRISDELLE, which is a drug marketed by Sebela Ireland Ltd and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BRISDELLE profile page.

The generic ingredient in BRISDELLE is paroxetine mesylate. There are thirty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.
Summary for 204516
Tradename:BRISDELLE
Applicant:Sebela Ireland Ltd
Ingredient:paroxetine mesylate
Patents:4
Suppliers and Packaging for NDA: 204516
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516 NDA AUTHORIZED GENERIC Padagis US LLC 0574-0279 0574-0279-30 30 CAPSULE in 1 BOTTLE (0574-0279-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 7.5MG BASE
Approval Date:Jun 28, 2013TE:ABRLD:Yes
Patent:7,598,271Patent Expiration:May 4, 2025Product Flag?Substance Flag?YDelist Request?
Patent:8,658,663Patent Expiration:Apr 6, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
Patent:8,946,251Patent Expiration:Aug 4, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Expired US Patents for NDA 204516

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 5,874,447 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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