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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214133

Marketing Status: Prescription
Proprietary Name: RECORLEV
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214133
Product Number: 001
Approval Date: Dec 30, 2021
Applicant Holder Full Name: STRONGBRIDGE DUBLIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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