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Last Updated: September 19, 2020

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Details for New Drug Application (NDA): 078894

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NDA 078894 describes PRAMIPEXOLE DIHYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Anchen Pharms, Dr Reddys, Macleods Pharms Ltd, Sandoz Inc, Zydus Pharms, Aurobindo Pharma Ltd, Breckenridge Pharm, Glenmark Generics, Graviti Pharms, Heritage Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa Inc, and is included in twenty-eight NDAs. It is available from twenty-three 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-four suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Summary for 078894
Tradename:PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:Alembic Pharms Ltd
Ingredient:pramipexole dihydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078894
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 078894
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 078894 ANDA Alembic Pharmaceuticals Limited 46708-003 46708-003-90 90 TABLET in 1 BOTTLE (46708-003-90)
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 078894 ANDA Alembic Pharmaceuticals Limited 46708-004 46708-004-90 90 TABLET in 1 BOTTLE (46708-004-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Oct 8, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Oct 8, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 8, 2010TE:ABRLD:No

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