Details for New Drug Application (NDA): 022421
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The generic ingredient in MIRAPEX ER 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 022421
Tradename: | MIRAPEX ER |
Applicant: | Boehringer Ingelheim |
Ingredient: | pramipexole dihydrochloride |
Patents: | 2 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.375MG | ||||
Approval Date: | Feb 19, 2010 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 26, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 8, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF PARKINSON'S DISEASE |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.75MG | ||||
Approval Date: | Feb 19, 2010 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 26, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022421
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-001 | Feb 19, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-004 | Feb 19, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-003 | Feb 19, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-002 | Feb 19, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-005 | Feb 19, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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