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Details for New Drug Application (NDA): 020936

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NDA 020936 describes PAXIL CR, which is a drug marketed by Apotex Technologies and is included in one NDA. It is available from five suppliers. There are six patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PAXIL CR profile page.

The generic ingredient in PAXIL CR 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: 020936

Tradename:
PAXIL CR
Applicant:
Apotex Technologies
Ingredient:
paroxetine hydrochloride
Patents:6
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Pharmacology for NDA: 020936

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 020936

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 020936 NDA STAT RX USA LLC 16590-514 16590-514-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-514-30)
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 020936 NDA STAT RX USA LLC 16590-514 16590-514-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-514-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 12.5MG BASE
Approval Date:Feb 16, 1999TE: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: 020936

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 20004,839,177*PED► subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 19996,080,759*PED► subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 19994,721,723*PED► subscribe
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