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Product Details for ANDA 211301

URSODIOL (URSODIOL)
300MG
Marketing Status: Prescription
Active Ingredient: URSODIOL
Proprietary Name: URSODIOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211301
Product Number: 001
Approval Date: Oct 16, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
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