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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
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Accenture
Teva
Citi
Express Scripts
Moodys
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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202633

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NDA 202633 describes PRAMIPEXOLE DIHYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Anchen Pharms, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Sandoz Inc, Zydus Pharms Usa 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, and Watson Labs, and is included in twenty-five NDAs. It is available from twenty-eight 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Summary for 202633
Tradename:PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:pramipexole dihydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202633
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 202633
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 202633 ANDA A-S Medication Solutions 50090-3280 N 50090-3280-0
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 202633 ANDA Rising Health, LLC 57237-180 N 57237-180-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Oct 26, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Oct 26, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 26, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
McKinsey
Cipla
Colorcon
Queensland Health
Fish and Richardson
Healthtrust
Moodys

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