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Details for New Drug Application (NDA): 020710

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NDA 020710 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: 020710

Apotex Technologies
paroxetine hydrochloride
Therapeutic Class:Antidepressants

Pharmacology for NDA: 020710

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 020710

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
paroxetine hydrochloride
SUSPENSION;ORAL 020710 NDA Apotex Corp 60505-0402 60505-0402-5 250 mL in 1 BOTTLE (60505-0402-5)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrengthEQ 10MG BASE/5ML
Approval Date:Jun 25, 1997TE:ABRLD:Yes
Patent:5,811,436*PEDPatent Expiration:Mar 22, 2016Product Flag?Substance Flag?Delist Request?Y
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?

Expired Orange Book Patents for NDA: 020710

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies
paroxetine hydrochloride
SUSPENSION;ORAL020710-001Jun 25, 19974,721,723*PED<subscribe>
Apotex Technologies
paroxetine hydrochloride
SUSPENSION;ORAL020710-001Jun 25, 19976,133,289*PED<subscribe>
Apotex Technologies
paroxetine hydrochloride
SUSPENSION;ORAL020710-001Jun 25, 19975,900,423*PED<subscribe>
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