Search results from the "OB_Rx" table for query on "021513."



Active Ingredient: DARIFENACIN HYDROBROMIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE; ORAL
Proprietary Name: ENABLEX
Applicant: NOVARTIS
Strength: EQ 7.5MG BASE
Application Number: 021513
Product Number: 001
Approval Date: Dec 22, 2004
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DARIFENACIN HYDROBROMIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE; ORAL
Proprietary Name: ENABLEX
Applicant: NOVARTIS
Strength: EQ 15MG BASE
Application Number: 021513
Product Number: 002
Approval Date: Dec 22, 2004
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
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:
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    Orange Book Data Updated Through October, 2009
    Patent and Generic Drug Product Data Last Updated: November 20, 2009