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U.S. Department of Health and Human Services

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

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through July 2014
Patent and Generic Drug Product Data Last Updated August 27, 2014

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