Details for New Drug Application (NDA): 020667
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The generic ingredient in MIRAPEX 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 020667
Tradename: | MIRAPEX |
Applicant: | Boehringer Ingelheim |
Ingredient: | pramipexole dihydrochloride |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 1, 1997 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 1, 1997 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 1, 1997 | TE: | RLD: | Yes |
Expired US Patents for NDA 020667
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-003 | Jul 1, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-007 | Jul 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-006 | Feb 12, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-001 | Jul 1, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-005 | Jul 1, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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