Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214962

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TASCENSO ODT (FINGOLIMOD LAURYL SULFATE)
EQ 0.25MG BASE
Marketing Status: Prescription

Active Ingredient: FINGOLIMOD LAURYL SULFATE
Proprietary Name: TASCENSO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 0.25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214962
Product Number: 001
Approval Date: Dec 23, 2021
Applicant Holder Full Name: CYCLE PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

TASCENSO ODT (FINGOLIMOD LAURYL SULFATE)
EQ 0.5MG BASE
Marketing Status: Prescription

Active Ingredient: FINGOLIMOD LAURYL SULFATE
Proprietary Name: TASCENSO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 0.5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214962
Product Number: 002
Approval Date: Dec 9, 2022
Applicant Holder Full Name: CYCLE PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information