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Serving 500+ biopharmaceutical companies globally:

Deloitte
Teva
Citi
Medtronic
Cantor Fitzgerald
US Department of Justice
Federal Trade Commission
Queensland Health
Dow
Merck

Generated: July 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201963

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NDA 201963 describes PRAMIPEXOLE DIHYDROCHLORIDE, which is a drug marketed by Strides Pharma, Anchen Pharms, Actavis Elizabeth, Zydus Pharms Usa Inc, Barr, Aurobindo Pharma Ltd, Teva Pharms, Breckenridge Pharm, Apotex Inc, Watson Labs, Sandoz Inc, Dr Reddys Labs Ltd, Actavis Grp Ptc, Mylan, Sciegen Pharms Inc, Macleods Pharms Ltd, Torrent Pharms, Glenmark Generics, Sun Pharm Inds Inc, Sandoz, and Alembic Pharms Ltd, and is included in twenty-four NDAs. It is available from thirty suppliers. Additional details are available on the PRAMIPEXOLE DIHYDROCHLORIDE profile page.

The generic ingredient in PRAMIPEXOLE DIHYDROCHLORIDE is pramipexole dihydrochloride. There are twenty-four drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for NDA: 201963

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.375MG
Approval Date:Apr 21, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.75MG
Approval Date:Apr 21, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1.5MG
Approval Date:Apr 21, 2016TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Teva
Farmers Insurance
Boehringer Ingelheim
Daiichi Sankyo
Covington
Accenture
AstraZeneca
Fish and Richardson
McKinsey
Fuji

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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