Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_Rx" table for query
on "020538."
| Active Ingredient: |
ESTRADIOL |
| Dosage Form;Route: |
FILM, EXTENDED RELEASE; TRANSDERMAL |
| Proprietary Name: |
VIVELLE-DOT |
| Applicant: |
NOVARTIS |
| Strength: |
0.0375MG/24HR |
| Application Number: |
N020538 |
| Product Number: |
005 |
| Approval Date: |
Jan 8, 1999 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
BX |
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
ESTRADIOL |
| Dosage Form;Route: |
FILM, EXTENDED RELEASE; TRANSDERMAL |
| Proprietary Name: |
VIVELLE-DOT |
| Applicant: |
NOVARTIS |
| Strength: |
0.05MG/24HR |
| Application Number: |
N020538 |
| Product Number: |
006 |
| Approval Date: |
Jan 8, 1999 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
AB1 |
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
ESTRADIOL |
| Dosage Form;Route: |
FILM, EXTENDED RELEASE; TRANSDERMAL |
| Proprietary Name: |
VIVELLE-DOT |
| Applicant: |
NOVARTIS |
| Strength: |
0.075MG/24HR |
| Application Number: |
N020538 |
| Product Number: |
007 |
| Approval Date: |
Jan 8, 1999 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
BX |
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
ESTRADIOL |
| Dosage Form;Route: |
FILM, EXTENDED RELEASE; TRANSDERMAL |
| Proprietary Name: |
VIVELLE-DOT |
| Applicant: |
NOVARTIS |
| Strength: |
0.1MG/24HR |
| Application Number: |
N020538 |
| Product Number: |
008 |
| Approval Date: |
Jan 8, 1999 |
| Reference Listed Drug |
Yes |
| RX/OTC/DISCN: |
RX |
| TE Code: |
AB1 |
| Patent and Exclusivity Info for this product: |
View |
|
| Active Ingredient: |
ESTRADIOL |
| Dosage Form;Route: |
FILM, EXTENDED RELEASE; TRANSDERMAL |
| Proprietary Name: |
VIVELLE-DOT |
| Applicant: |
NOVARTIS |
| Strength: |
0.025MG/24HR |
| Application Number: |
N020538 |
| Product Number: |
009 |
| Approval Date: |
May 3, 2002 |
| Reference Listed Drug |
No |
| RX/OTC/DISCN: |
RX |
| TE Code: |
BX |
| Patent and Exclusivity Info for this product: |
View |
|
Return to Electronic Orange Book Home Page
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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 May, 2013
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Patent and Generic Drug Product Data Last Updated: June 18, 2013
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