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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206333

20MG/2ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: DEOXYCHOLIC ACID
Proprietary Name: KYBELLA
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 20MG/2ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N206333
Product Number: 001
Approval Date: Apr 29, 2015
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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