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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205750

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CHOLBAM (CHOLIC ACID)
50MG
Marketing Status: Prescription
Active Ingredient: CHOLIC ACID
Proprietary Name: CHOLBAM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205750
Product Number: 001
Approval Date: Mar 17, 2015
Applicant Holder Full Name: MIRUM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
CHOLBAM (CHOLIC ACID)
250MG
Marketing Status: Prescription
Active Ingredient: CHOLIC ACID
Proprietary Name: CHOLBAM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205750
Product Number: 002
Approval Date: Mar 17, 2015
Applicant Holder Full Name: MIRUM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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