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Details for New Drug Application (NDA): 202702

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NDA 202702 describes PRAMIPEXOLE DIHYDROCHLORIDE, which is a drug marketed by Strides Pharma, Anchen Pharms, Actavis Elizabeth, Zydus Pharms Usa Inc, Barr, Aurobindo Pharma Ltd, Teva Pharms, Breckenridge Pharm, Apotex Inc, Watson Labs, Sandoz Inc, Dr Reddys Labs Ltd, Actavis Grp Ptc, Mylan, Sciegen Pharms Inc, Macleods Pharms Ltd, Torrent Pharms, Glenmark Generics, Sun Pharm Inds Inc, Sandoz, and Alembic Ltd, and is included in twenty-four NDAs. It is available from thirty-two 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-three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for NDA: 202702

Tradename:
PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:
Strides Pharma
Ingredient:
pramipexole dihydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 202702

Mechanism of ActionDopamine Agonists

Suppliers and Packaging for NDA: 202702

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride
TABLET;ORAL 202702 ANDA Strides Arcolab Limited 64380-746 64380-746-05 90 TABLET in 1 BOTTLE (64380-746-05)
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride
TABLET;ORAL 202702 ANDA Strides Arcolab Limited 64380-747 64380-747-01 10 BLISTER PACK in 1 CARTON (64380-747-01) > 10 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Jun 3, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jun 3, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jun 3, 2014TE:ABRLD:No


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