Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_Rx" table for query
on "020667."
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET; ORAL |
| Proprietary Name: |
MIRAPEX |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
0.125MG |
| Application Number: |
N020667 |
| Product Number: |
001 |
| Approval Date: |
Jul 1, 1997 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
AB |
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET; ORAL |
| Proprietary Name: |
MIRAPEX |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
0.25MG |
| Application Number: |
N020667 |
| Product Number: |
002 |
| Approval Date: |
Jul 1, 1997 |
| Reference Listed Drug |
Yes |
| RX/OTC/DISCN: |
RX |
| TE Code: |
AB |
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET; ORAL |
| Proprietary Name: |
MIRAPEX |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
1MG |
| Application Number: |
N020667 |
| Product Number: |
003 |
| Approval Date: |
Jul 1, 1997 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
AB |
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET; ORAL |
| Proprietary Name: |
MIRAPEX |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
1.5MG |
| Application Number: |
N020667 |
| Product Number: |
005 |
| Approval Date: |
Jul 1, 1997 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
AB |
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET; ORAL |
| Proprietary Name: |
MIRAPEX |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
0.5MG |
| Application Number: |
N020667 |
| Product Number: |
006 |
| Approval Date: |
Feb 12, 1998 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
AB |
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET; ORAL |
| Proprietary Name: |
MIRAPEX |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
0.75MG |
| Application Number: |
N020667 |
| Product Number: |
007 |
| Approval Date: |
Jul 30, 2007 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
AB |
| Patent and Exclusivity Info for this product: |
View |
|
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FDA/Center for Drug Evaluation and Research
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Office of Generic Drugs
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Division of Labeling and Program Support
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Update Frequency: |
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Orange Book Data - Monthly
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Generic Drug Product Information & Patent Information - Daily
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Orange Book Data Updated Through April, 2013
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Patent and Generic Drug Product Data Last Updated: May 17, 2013
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