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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 204518


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NDA 204518 describes PRAMIPEXOLE DIHYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic, Dr Reddys, Endo Operations, Macleods Pharms Ltd, Novast Labs, Sandoz, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharma Avet, Natco, Natco Pharma, Nostrum Labs Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, Zennova, and Zydus Pharms Usa Inc, and is included in thirty 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-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Summary for 204518
Tradename:PRAMIPEXOLE DIHYDROCHLORIDE
Applicant:Alembic
Ingredient:pramipexole dihydrochloride
Patents:0
Pharmacology for NDA: 204518
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 204518
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 204518 ANDA Alembic Pharmaceuticals Limited 46708-574 46708-574-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-574-30)
PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 204518 ANDA Alembic Pharmaceuticals Limited 46708-575 46708-575-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-575-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.375MG
Approval Date:Jan 2, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.75MG
Approval Date:Jan 2, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1.5MG
Approval Date:Jan 2, 2019TE:ABRLD:No

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