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Generated: November 15, 2018

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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 two suppliers. 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. Four 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
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
BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516 NDA Paddock Laboratories, LLC 0574-0279 0574-0279-30 30 CAPSULE in 1 BOTTLE (0574-0279-30)
BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516 NDA Sebela Pharmaceuticals Inc. 54766-907 54766-907-53 30 CAPSULE in 1 BLISTER PACK (54766-907-53)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 7.5MG BASE
Approval Date:Jun 28, 2013TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:May 4, 2025Product Flag?Substance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Apr 6, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
Patent:➤ Try a Free TrialPatent Expiration:Aug 4, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

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