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Details for New Drug Application (NDA): 020667

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NDA 020667 describes MIRAPEX, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from five suppliers. There are four patents protecting this drug and five Paragraph IV challenges. Additional details are available on the MIRAPEX profile page.

The generic ingredient in MIRAPEX 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: 020667

Tradename:
MIRAPEX
Applicant:
Boehringer Ingelheim
Ingredient:
pramipexole dihydrochloride
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 020667

Mechanism of ActionDopamine Agonists

Suppliers and Packaging for NDA: 020667

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL 020667 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0101 0597-0101-90 90 TABLET in 1 BOTTLE (0597-0101-90)
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL 020667 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0183 0597-0183-90 90 TABLET in 1 BOTTLE (0597-0183-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Jul 1, 1997TE:ABRLD:No
Patent:6,001,861Patent Expiration:Jan 16, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)
Patent:6,194,445Patent Expiration:Jan 16, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 1, 1997TE:ABRLD:Yes
Patent:6,001,861Patent Expiration:Jan 16, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)

Expired Orange Book Patents for NDA: 020667

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-005Jul 1, 19974,866,812► subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-005Jul 1, 19974,886,812► subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-003Jul 1, 19974,843,086► subscribe
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