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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
Merck
Fish and Richardson
Moodys
US Department of Justice
Harvard Business School
US Army
Farmers Insurance
UBS

Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091427

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NDA 091427 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-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 091427

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

Pharmacology for NDA: 091427

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 091427

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 091427 ANDA Mylan Pharmaceuticals Inc. 0378-2005 0378-2005-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2005-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 37.5MG BASE
Approval Date:Apr 14, 2011TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Deloitte
Baxter
Cerilliant
Fish and Richardson
US Department of Justice
McKesson
Federal Trade Commission
US Army
Cantor Fitzgerald

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.

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