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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 021299


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NDA 021299 describes PEXEVA, which is a drug marketed by Sebela Ireland Ltd and is included in one NDA. There is one patent protecting this drug. Additional details are available on the PEXEVA profile page.

The generic ingredient in PEXEVA 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 021299
Tradename:PEXEVA
Applicant:Sebela Ireland Ltd
Ingredient:paroxetine mesylate
Patents:1

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 3, 2003TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 4, 2025Product Flag?Substance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jul 3, 2003TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 4, 2025Product Flag?Substance Flag?YDelist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Jul 3, 2003TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 4, 2025Product Flag?Substance Flag?YDelist Request?

Expired US Patents for NDA 021299

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-002 Jul 3, 2003 ⤷  Sign Up ⤷  Sign Up
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-001 Jul 3, 2003 ⤷  Sign Up ⤷  Sign Up
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-004 Jul 3, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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