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Generated: October 16, 2018

DrugPatentWatch Database Preview

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. It is available from two suppliers. 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. Four 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021299
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 021299
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEXEVA paroxetine mesylate TABLET;ORAL 021299 NDA Sebela Pharmaceuticals Inc. 54766-201 54766-201-01 30 TABLET, FILM COATED in 1 BOTTLE (54766-201-01)
PEXEVA paroxetine mesylate TABLET;ORAL 021299 NDA Sebela Pharmaceuticals Inc. 54766-202 54766-202-01 30 TABLET, FILM COATED in 1 BOTTLE (54766-202-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 3, 2003TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:May 4, 2025Product Flag?Substance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jul 3, 2003TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:May 4, 2025Product Flag?Substance Flag?YDelist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Jul 3, 2003TE:RLD:Yes
Patent:➤ Try a Free TrialPatent 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 021299-001 Jul 3, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-003 Jul 3, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-004 Jul 3, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-002 Jul 3, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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