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Details for New Drug Application (NDA): 203854

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NDA 203854 describes PAROXETINE, which is a drug marketed by Prinston Inc, Mylan, Aurobindo Pharma, Mylan Pharms Inc, Teva, Roxane, Jubilant Generics, Kremers Urban Pharms, Apotex, Upsher-smith Labs, Oxford Pharms, Teva Pharms, Zydus Pharms Usa, Sun Pharm Inds Inc, and Apotex Inc, and is included in seventeen NDAs. It is available from four suppliers. Additional details are available on the PAROXETINE profile page.

The generic ingredient in PAROXETINE 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: 203854

Tradename:
PAROXETINE
Applicant:
Prinston Inc
Ingredient:
paroxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Pharmacology for NDA: 203854

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 203854

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE
paroxetine hydrochloride
TABLET;ORAL 203854 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7985 0615-7985-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-05)
PAROXETINE
paroxetine hydrochloride
TABLET;ORAL 203854 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7985 0615-7985-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Oct 31, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Oct 31, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Oct 31, 2014TE:ABRLD:No


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