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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203855

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NDA 203855 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 203855
Tradename:PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:Sciegen Pharms Inc
Ingredient:pramipexole dihydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203855
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 203855
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 203855 ANDA Camber Pharmaceuticals, Inc. 31722-906 N 31722-906-05
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 203855 ANDA Camber Pharmaceuticals, Inc. 31722-906 N 31722-906-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Oct 28, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Oct 28, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 28, 2014TE:ABRLD:No

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