Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214980

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OBETICHOLIC ACID (OBETICHOLIC ACID)
5MG
Marketing Status: Discontinued

Active Ingredient: OBETICHOLIC ACID
Proprietary Name: OBETICHOLIC ACID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214980
Product Number: 001
Approval Date: May 30, 2023
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

OBETICHOLIC ACID (OBETICHOLIC ACID)
10MG
Marketing Status: Discontinued

Active Ingredient: OBETICHOLIC ACID
Proprietary Name: OBETICHOLIC ACID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214980
Product Number: 002
Approval Date: May 30, 2023
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information