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Details for New Drug Application (NDA): 020031

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NDA 020031 describes PAXIL, which is a drug marketed by Apotex Technologies and is included in four NDAs. It is available from two suppliers. There are ten patents protecting this drug and three Paragraph IV challenges. Additional details are available on the PAXIL profile page.

The generic ingredient in PAXIL is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

Summary for NDA: 020031

Tradename:
PAXIL
Applicant:
Apotex Technologies
Ingredient:
paroxetine hydrochloride
Patents:4
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Pharmacology for NDA: 020031

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 020031

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAXIL
paroxetine hydrochloride
TABLET;ORAL 020031 NDA Physicians Total Care, Inc. 54868-2976 54868-2976-2 30 TABLET, FILM COATED in 1 BOTTLE (54868-2976-2)
PAXIL
paroxetine hydrochloride
TABLET;ORAL 020031 NDA Physicians Total Care, Inc. 54868-2976 54868-2976-3 60 TABLET, FILM COATED in 1 BOTTLE (54868-2976-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Dec 29, 1992TE:ABRLD:No
Patent:5,872,132*PEDPatent Expiration:Nov 19, 2015Product Flag?Substance Flag?Delist Request?
Patent:5,900,423*PEDPatent Expiration:Nov 19, 2015Product Flag?Substance Flag?Delist Request?
Patent:6,121,291*PEDPatent Expiration:Sep 17, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020031

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-002Dec 29, 19924,721,723*PED► subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-005Dec 29, 19926,113,944*PED► subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-004Dec 29, 19926,133,289*PED► subscribe
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