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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077873

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NDA 077873 describes PAROXETINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Kremers Urban Pharms, Lupin Ltd, Mylan, Apotex, Aurobindo Pharma, Jubilant Generics, Mylan Pharms Inc, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva, Teva Pharms, Upsher-smith Labs, and Zydus Pharms Usa, and is included in seventeen NDAs. It is available from fifty-three suppliers. Additional details are available on the PAROXETINE HYDROCHLORIDE profile page.

The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

Summary for 077873

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Pharmacology for NDA: 077873

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 077873

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077873 ANDA Mylan Pharmaceuticals Inc. 0378-2003 0378-2003-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2003-05)
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077873 ANDA Mylan Pharmaceuticals Inc. 0378-2003 0378-2003-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2003-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 12.5MG BASE
Approval Date:Jun 29, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG BASE
Approval Date:Jun 29, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
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QuintilesIMS
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