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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019594

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ACTIGALL (URSODIOL)
300MG
Marketing Status: Prescription
Active Ingredient: URSODIOL
Proprietary Name: ACTIGALL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019594
Product Number: 002
Approval Date: Dec 31, 1987
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ACTIGALL (URSODIOL)
150MG
Marketing Status: Discontinued
Active Ingredient: URSODIOL
Proprietary Name: ACTIGALL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019594
Product Number: 001
Approval Date: Dec 31, 1987
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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