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:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jul 3, 2003	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	May 4, 2025	Product Flag?		Substance Flag?	Y	Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jul 3, 2003	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	May 4, 2025	Product Flag?		Substance Flag?	Y	Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 30MG BASE
Approval Date:	Jul 3, 2003	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	May 4, 2025	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 021299

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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	⤷ Sign Up	⤷ Sign Up
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	021299-003	Jul 3, 2003	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-004	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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