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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

AstraZeneca
US Army
Julphar
McKinsey
Chubb
Queensland Health
Accenture
Express Scripts
Dow
Deloitte

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202164

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NDA 202164 describes PRAMIPEXOLE DIHYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Anchen Pharms, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Sandoz Inc, Actavis Grp Ptc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr, Breckenridge Pharm, Glenmark Generics, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Teva Pharms, Torrent Pharms, Watson Labs, and Zydus Pharms Usa Inc, and is included in twenty-four NDAs. It is available from twenty-nine 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 suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for 202164

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 202164

Mechanism of ActionDopamine Agonists

Suppliers and Packaging for NDA: 202164

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 202164 ANDA Macleods Pharmaceuticals Limited 33342-031 33342-031-10 90 TABLET in 1 BOTTLE (33342-031-10)
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 202164 ANDA Macleods Pharmaceuticals Limited 33342-031 33342-031-15 500 TABLET in 1 BOTTLE (33342-031-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Sep 20, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Sep 20, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Sep 20, 2012TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Daiichi Sankyo
AstraZeneca
Fish and Richardson
Harvard Business School
QuintilesIMS
Queensland Health
Healthtrust
Accenture
Cerilliant

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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