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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Chubb
Express Scripts
Colorcon
Baxter
Julphar
Chinese Patent Office
Dow
Fuji
Johnson and Johnson

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078194

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NDA 078194 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 078194

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

Pharmacology for NDA: 078194

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 078194

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL 078194 ANDA Sun Pharmaceutical Industries, Inc. 57664-421 57664-421-08 100 TABLET in 1 BOTTLE (57664-421-08)
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL 078194 ANDA Sun Pharmaceutical Industries, Inc. 57664-421 57664-421-13 500 TABLET in 1 BOTTLE (57664-421-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jun 29, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jun 29, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Jun 29, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Teva
Chubb
Farmers Insurance
Argus Health
Federal Trade Commission
QuintilesIMS
Fish and Richardson
McKinsey
Citi
Baxter

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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