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Generated: October 22, 2018

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Details for New Drug Application (NDA): 090781

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NDA 090781 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, Cspc Ouyi Pharm Co, 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-six NDAs. It is available from twenty-six 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-seven suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Summary for 090781
Tradename:PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:Glenmark Generics
Ingredient:pramipexole dihydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090781
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 090781
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090781 ANDA Glenmark Pharmaceuticals Inc., USA 68462-330 68462-330-05 500 TABLET in 1 BOTTLE (68462-330-05)
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090781 ANDA Glenmark Pharmaceuticals Inc., USA 68462-330 68462-330-11 10 BLISTER PACK in 1 CARTON (68462-330-11) > 10 TABLET in 1 BLISTER PACK

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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