Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_Rx" table for query
on "021976."
| Active Ingredient: |
DARUNAVIR ETHANOLATE |
| Dosage Form;Route: |
TABLET; ORAL |
| Proprietary Name: |
PREZISTA |
| Applicant: |
JANSSEN PRODS |
| Strength: |
EQ 600MG BASE |
| Application Number: |
N021976 |
| Product Number: |
002 |
| Approval Date: |
Feb 25, 2008 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
DARUNAVIR ETHANOLATE |
| Dosage Form;Route: |
TABLET; ORAL |
| Proprietary Name: |
PREZISTA |
| Applicant: |
JANSSEN PRODS |
| Strength: |
EQ 400MG BASE |
| Application Number: |
N021976 |
| Product Number: |
003 |
| Approval Date: |
Oct 21, 2008 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
DARUNAVIR ETHANOLATE |
| Dosage Form;Route: |
TABLET; ORAL |
| Proprietary Name: |
PREZISTA |
| Applicant: |
JANSSEN PRODS |
| Strength: |
EQ 75MG BASE |
| Application Number: |
N021976 |
| Product Number: |
004 |
| Approval Date: |
Dec 18, 2008 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
DARUNAVIR ETHANOLATE |
| Dosage Form;Route: |
TABLET; ORAL |
| Proprietary Name: |
PREZISTA |
| Applicant: |
JANSSEN PRODS |
| Strength: |
EQ 150MG BASE |
| Application Number: |
N021976 |
| Product Number: |
005 |
| Approval Date: |
Dec 18, 2008 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
|
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
DARUNAVIR ETHANOLATE |
| Dosage Form;Route: |
TABLET; ORAL |
| Proprietary Name: |
PREZISTA |
| Applicant: |
JANSSEN PRODS |
| Strength: |
EQ 800MG BASE |
| Application Number: |
N021976 |
| Product Number: |
006 |
| Approval Date: |
Nov 9, 2012 |
| Reference Listed Drug |
Yes |
| 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 22, 2013
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