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Serving leading biopharmaceutical companies globally:

Chubb
Teva
Cerilliant
Medtronic
Express Scripts
McKesson
Healthtrust
Cipla
Dow
Boehringer Ingelheim

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202353

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NDA 202353 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 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 202353
Tradename:PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:Sandoz Inc
Ingredient:pramipexole dihydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.375MG
Approval Date:Dec 4, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.75MG
Approval Date:Dec 4, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1.5MG
Approval Date:Dec 4, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

McKesson
McKinsey
Express Scripts
Covington
Julphar
Fuji
Cantor Fitzgerald
Colorcon
Novartis

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