Search results from the "OB_Rx" table for query on "020675."



Active Ingredient: URSODIOL
Dosage Form;Route: TABLET; ORAL
Proprietary Name: URSO 250
Applicant: AXCAN
Strength: 250MG
Application Number: 020675
Product Number: 001
Approval Date: Dec 10, 1997
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: URSODIOL
Dosage Form;Route: TABLET; ORAL
Proprietary Name: URSO FORTE
Applicant: AXCAN
Strength: 500MG
Application Number: 020675
Product Number: 002
Approval Date: Jul 21, 2004
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
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