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Fish and Richardson
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Covington
McKesson
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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202206

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NDA 202206 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-seven 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-eight suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Summary for 202206
Tradename:PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:Anchen Pharms
Ingredient:pramipexole dihydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202206
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 202206
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202206 ANDA Par Pharmaceutical, Inc. 10370-251 N 10370-251-11
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202206 ANDA Par Pharmaceutical, Inc. 10370-252 N 10370-252-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.375MG
Approval Date:Feb 6, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.75MG
Approval Date:Feb 6, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1.5MG
Approval Date:Feb 6, 2014TE:ABRLD:No

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Federal Trade Commission
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