Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_Rx" table for query
on "021346."
| Active Ingredient: |
RISPERIDONE |
| Dosage Form;Route: |
INJECTABLE; INTRAMUSCULAR |
| Proprietary Name: |
RISPERDAL CONSTA |
| Applicant: |
JANSSEN PHARMS |
| Strength: |
25MG/VIAL |
| Application Number: |
N021346 |
| Product Number: |
001 |
| Approval Date: |
Oct 29, 2003 |
| Reference Listed Drug |
Yes |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
RISPERIDONE |
| Dosage Form;Route: |
INJECTABLE; INTRAMUSCULAR |
| Proprietary Name: |
RISPERDAL CONSTA |
| Applicant: |
JANSSEN PHARMS |
| Strength: |
37.5MG/VIAL |
| Application Number: |
N021346 |
| Product Number: |
002 |
| Approval Date: |
Oct 29, 2003 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
RISPERIDONE |
| Dosage Form;Route: |
INJECTABLE; INTRAMUSCULAR |
| Proprietary Name: |
RISPERDAL CONSTA |
| Applicant: |
JANSSEN PHARMS |
| Strength: |
50MG/VIAL |
| Application Number: |
N021346 |
| Product Number: |
003 |
| Approval Date: |
Oct 29, 2003 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
RISPERIDONE |
| Dosage Form;Route: |
INJECTABLE; INTRAMUSCULAR |
| Proprietary Name: |
RISPERDAL CONSTA |
| Applicant: |
JANSSEN PHARMS |
| Strength: |
12.5MG/VIAL |
| Application Number: |
N021346 |
| Product Number: |
004 |
| Approval Date: |
Apr 12, 2007 |
| 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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