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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 "022334."



Active Ingredient: EVEROLIMUS
Dosage Form;Route: TABLET;ORAL
Proprietary Name: AFINITOR
Applicant: NOVARTIS
Strength: 5MG
Application Number: N022334
Product Number: 001
Approval Date: Mar 30, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: EVEROLIMUS
Dosage Form;Route: TABLET;ORAL
Proprietary Name: AFINITOR
Applicant: NOVARTIS
Strength: 10MG
Application Number: N022334
Product Number: 002
Approval Date: Mar 30, 2009
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: EVEROLIMUS
Dosage Form;Route: TABLET;ORAL
Proprietary Name: AFINITOR
Applicant: NOVARTIS
Strength: 2.5MG
Application Number: N022334
Product Number: 003
Approval Date: Jul 9, 2010
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: EVEROLIMUS
Dosage Form;Route: TABLET;ORAL
Proprietary Name: AFINITOR
Applicant: NOVARTIS
Strength: 7.5MG
Application Number: N022334
Product Number: 004
Approval Date: Mar 30, 2012
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
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 October 2014
Patent and Generic Drug Product Data Last Updated November 26, 2014

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