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Serving leading biopharmaceutical companies globally:

McKinsey
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078902

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NDA 078902 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 078902

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

Pharmacology for NDA: 078902

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 078902

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078902 ANDA Mylan Pharmaceuticals Inc. 0378-7001 0378-7001-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-10)
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078902 ANDA Mylan Pharmaceuticals Inc. 0378-7001 0378-7001-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Mar 13, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Mar 13, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Mar 13, 2008TE:ABRLD:No


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Chinese Patent Office

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