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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 202206


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NDA 202206 describes PRAMIPEXOLE DIHYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic, Chartwell Rx, Dr Reddys, Macleods Pharms Ltd, Novast Labs, Ph Health, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Heritage Pharma Avet, Natco, Natco Pharma, Pharmobedient, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, and Zydus Pharms Usa Inc, and is included in thirty NDAs. It is available from twenty-two suppliers. Additional details are available on the PRAMIPEXOLE DIHYDROCHLORIDE profile page.

The generic ingredient in PRAMIPEXOLE DIHYDROCHLORIDE is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Summary for 202206
Tradename:PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:Ph Health
Ingredient:pramipexole dihydrochloride
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength0.375MG
Approval Date:Feb 6, 2014TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength0.75MG
Approval Date:Feb 6, 2014TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength1.5MG
Approval Date:Feb 6, 2014TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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