Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Fuji
Merck
Federal Trade Commission
Fish and Richardson
Novartis
QuintilesIMS
Johnson and Johnson
Julphar
Dow
Argus Health

Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077873

« Back to Dashboard
NDA 077873 describes PAROXETINE HYDROCHLORIDE, which is a drug marketed by Mylan, Aurobindo Pharma, Mylan Pharms Inc, Teva, Roxane, Jubilant Generics, Lupin Ltd, 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 fifty-two 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-five suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

Summary for NDA: 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


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
UBS
Fuji
Farmers Insurance
Mallinckrodt
US Department of Justice
Boehringer Ingelheim
Chubb
Johnson and Johnson
Fish and Richardson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot