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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 five 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 NDA: 204516

Sebela Ireland Ltd
paroxetine mesylate
Formulation / Manufacturing:see details

Pharmacology for NDA: 204516

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 204516

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
paroxetine mesylate
CAPSULE;ORAL 204516 NDA Noven Therapeutics, LLC 68968-9075 68968-9075-3 30 CAPSULE in 1 BLISTER PACK (68968-9075-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 7.5MG BASE
Approval Date:Jun 28, 2013TE:RLD:Yes
Patent:5,874,447Patent Expiration:Jun 10, 2017Product Flag?Substance Flag?YDelist Request?
Patent:7,598,271Patent Expiration:May 4, 2025Product Flag?Substance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Jun 28, 2016
Regulatory Exclusivity Use:NEW PRODUCT

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.