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Details for Generic Name: paroxetine hydrochloride

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Paroxetine hydrochloride is the generic ingredient in four branded drugs marketed by Apotex Technologies, Apotex Inc, Mylan, Prinston Inc, Apotex, Aurobindo Pharma, Mylan Pharms Inc, Prosam Labs, Roxane, Sandoz, Sun Pharm Inds Inc, Teva, Teva Pharms, and Zydus Pharms Usa, and is included in nineteen NDAs. There are eleven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for paroxetine hydrochloride. Five suppliers are listed for this compound.

Summary for Generic Name: paroxetine hydrochloride

Drug Master File Entries: see list29
Suppliers / Packaging: see list32
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for Ingredient: paroxetine hydrochloride

Clinical Trials for: paroxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Technologies
paroxetine hydrochloride
CAPSULE;ORAL020885-003Oct 9, 1998DISCNNo6,063,927*PED<disabled>Y<disabled>
paroxetine hydrochloride
TABLET;ORAL075356-003Jul 30, 2003RXNo<disabled><disabled>
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL077873-001Jun 29, 2007RXNo<disabled><disabled>
Apotex Technologies
paroxetine hydrochloride
CAPSULE;ORAL020885-001Oct 9, 1998DISCNNo6,121,291*PED<disabled>Y<disabled>
Apotex Technologies
paroxetine hydrochloride
CAPSULE;ORAL020885-002Oct 9, 1998DISCNNo5,872,132*PED<disabled>Y<disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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