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:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 7.5MG BASE
Approval Date:	Jun 28, 2013	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	May 4, 2025	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Apr 6, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
Patent:	⤷ Sign Up	Patent Expiration:	Aug 4, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Expired US Patents for NDA 204516

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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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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