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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206156

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NDA 206156 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 twenty-nine 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 suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for 206156

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 206156

Mechanism of ActionDopamine Agonists

Suppliers and Packaging for NDA: 206156

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 206156 ANDA Macleods Pharmaceuticals Limited 33342-208 33342-208-07 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-208-07)
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 206156 ANDA Macleods Pharmaceuticals Limited 33342-208 33342-208-12 10 BLISTER PACK in 1 CARTON (33342-208-12) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.375MG
Approval Date:Jun 24, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.75MG
Approval Date:Jun 24, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1.5MG
Approval Date:Jun 24, 2016TE:ABRLD:No


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