Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_Rx" table for query
on "022421."
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET, EXTENDED RELEASE; ORAL |
| Proprietary Name: |
MIRAPEX ER |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
0.375MG |
| Application Number: |
N022421 |
| Product Number: |
001 |
| Approval Date: |
Feb 19, 2010 |
| Reference Listed Drug |
Yes |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET, EXTENDED RELEASE; ORAL |
| Proprietary Name: |
MIRAPEX ER |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
0.75MG |
| Application Number: |
N022421 |
| Product Number: |
002 |
| Approval Date: |
Feb 19, 2010 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET, EXTENDED RELEASE; ORAL |
| Proprietary Name: |
MIRAPEX ER |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
1.5MG |
| Application Number: |
N022421 |
| Product Number: |
003 |
| Approval Date: |
Feb 19, 2010 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET, EXTENDED RELEASE; ORAL |
| Proprietary Name: |
MIRAPEX ER |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
3MG |
| Application Number: |
N022421 |
| Product Number: |
004 |
| Approval Date: |
Feb 19, 2010 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET, EXTENDED RELEASE; ORAL |
| Proprietary Name: |
MIRAPEX ER |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
4.5MG |
| Application Number: |
N022421 |
| Product Number: |
005 |
| Approval Date: |
Feb 19, 2010 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET, EXTENDED RELEASE; ORAL |
| Proprietary Name: |
MIRAPEX ER |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
2.25MG |
| Application Number: |
N022421 |
| Product Number: |
006 |
| Approval Date: |
Jun 17, 2011 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form;Route: |
TABLET, EXTENDED RELEASE; ORAL |
| Proprietary Name: |
MIRAPEX ER |
| Applicant: |
BOEHRINGER INGELHEIM |
| Strength: |
3.75MG |
| Application Number: |
N022421 |
| Product Number: |
007 |
| Approval Date: |
Jun 17, 2011 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| 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 24, 2013
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