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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Fish and Richardson
Boehringer Ingelheim
Daiichi Sankyo
Baxter
Teva
Argus Health
Colorcon
Johnson and Johnson

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078920

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NDA 078920 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-seven 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-eight suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Summary for 078920
Tradename:PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:Zydus Pharms Usa Inc
Ingredient:pramipexole dihydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078920
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 078920
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 078920 ANDA KAISER FOUNDATION HOSPITALS 0179-0083 N 0179-0083-70
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 078920 ANDA A-S Medication Solutions 50090-1388 N 50090-1388-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Jul 6, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 6, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jul 6, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Dow
US Department of Justice
Fish and Richardson
Cipla
Cantor Fitzgerald
Chubb
Queensland Health

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