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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091683

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NDA 091683 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-eight 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-nine suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for 091683

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

Pharmacology for NDA: 091683

Mechanism of ActionDopamine Agonists

Suppliers and Packaging for NDA: 091683

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 091683 ANDA Caraco Pharmaceutical Laboratories, Ltd. 57664-001 57664-001-83 30 TABLET in 1 BOTTLE (57664-001-83)
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 091683 ANDA Caraco Pharmaceutical Laboratories, Ltd. 57664-001 57664-001-18 1000 TABLET in 1 BOTTLE (57664-001-18)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Mar 27, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Mar 27, 2013TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Mar 27, 2013TE:ABRLD:No


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