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Profile for Tradename: PAXIL CR

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Paxil Cr 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.

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

Summary for Tradename: PAXIL CR

Patents:6
Applicants:1
NDAs:1
Suppliers: see list5

Pharmacology for Tradename: PAXIL CR

Clinical Trials for: PAXIL CR

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936Dec 6, 2000RXYes6,548,084*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936Dec 6, 2000RXYes5,900,423*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936Feb 16, 1999RXNo6,548,084*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936Feb 16, 1999RXNo5,872,132*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936Dec 6, 2000RXYes7,229,640*PED<disabled>Y<disabled>
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Paragraph IV activity for: PAXIL CR

Drugname Dosage Strength RLD Submissiondate
paroxetine hydrochlorideExtended-release Tablets37.5 mgPaxil CR5/19/2009
paroxetine hydrochlorideExtended-release Tablets25 mgPaxil CR9/9/2005
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