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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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Chinese Patent Office
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Generated: April 21, 2018

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, Zydus Pharms Usa 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, and Watson Labs, and is included in twenty-five NDAs. It is available from twenty-four 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-five suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Summary for 091683
Tradename:PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:Sun Pharm Inds Inc
Ingredient:pramipexole dihydrochloride
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 N 57664-001-83
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 091683 ANDA Caraco Pharmaceutical Laboratories, Ltd. 57664-001 N 57664-001-18

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Dow
Boehringer Ingelheim
Moodys
Chinese Patent Office
Healthtrust
Express Scripts
Covington
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