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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 are two patents 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 NDA: 021299

Tradename:
PEXEVA
Applicant:
Sebela Ireland Ltd
Ingredient:
paroxetine mesylate
Patents:2
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 REMEDYREPACK INC. 61786-603 61786-603-02 30 TABLET, FILM COATED in 1 BLISTER PACK (61786-603-02)
PEXEVA
paroxetine mesylate
TABLET;ORAL 021299 NDA NOVEN THERAPEUTICS, LLC 68968-2010 68968-2010-1 30 TABLET, FILM COATED in 1 BOTTLE (68968-2010-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 3, 2003TE:RLD:No
Patent:7,598,271Patent Expiration:May 4, 2025Product Flag?Substance Flag?YDelist Request?
Patent:5,874,447Patent Expiration:Jun 10, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:DEPRESSION
Patent:5,874,447Patent Expiration:Jun 10, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:OBSESSIVE COMPULSIVE DISORDER


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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.

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