Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211150

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WAKIX (PITOLISANT HYDROCHLORIDE)
EQ 4.45MG BASE
Marketing Status: Prescription

Active Ingredient: PITOLISANT HYDROCHLORIDE
Proprietary Name: WAKIX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4.45MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211150
Product Number: 001
Approval Date: Aug 14, 2019
Applicant Holder Full Name: HARMONY BIOSCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

WAKIX (PITOLISANT HYDROCHLORIDE)
EQ 17.8MG BASE
Marketing Status: Prescription

Active Ingredient: PITOLISANT HYDROCHLORIDE
Proprietary Name: WAKIX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 17.8MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211150
Product Number: 002
Approval Date: Aug 14, 2019
Applicant Holder Full Name: HARMONY BIOSCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information