Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020675

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URSO 250 (URSODIOL)
250MG
Marketing Status: Prescription

Active Ingredient: URSODIOL
Proprietary Name: URSO 250
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020675
Product Number: 001
Approval Date: Dec 10, 1997
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

URSO FORTE (URSODIOL)
500MG
Marketing Status: Prescription

Active Ingredient: URSODIOL
Proprietary Name: URSO FORTE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020675
Product Number: 002
Approval Date: Jul 21, 2004
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information