Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209899

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ZEPOSIA (OZANIMOD HYDROCHLORIDE)
EQ 0.23MG BASE
Marketing Status: Prescription
Active Ingredient: OZANIMOD HYDROCHLORIDE
Proprietary Name: ZEPOSIA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.23MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209899
Product Number: 001
Approval Date: Mar 25, 2020
Applicant Holder Full Name: CELGENE INTERNATIONAL II SARL
Marketing Status:  Prescription
Patent and Exclusivity Information
ZEPOSIA (OZANIMOD HYDROCHLORIDE)
EQ 0.46MG BASE
Marketing Status: Prescription
Active Ingredient: OZANIMOD HYDROCHLORIDE
Proprietary Name: ZEPOSIA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.46MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209899
Product Number: 002
Approval Date: Mar 25, 2020
Applicant Holder Full Name: CELGENE INTERNATIONAL II SARL
Marketing Status:  Prescription
Patent and Exclusivity Information
ZEPOSIA (OZANIMOD HYDROCHLORIDE)
EQ 0.92MG BASE
Marketing Status: Prescription
Active Ingredient: OZANIMOD HYDROCHLORIDE
Proprietary Name: ZEPOSIA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.92MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209899
Product Number: 003
Approval Date: Mar 25, 2020
Applicant Holder Full Name: CELGENE INTERNATIONAL II SARL
Marketing Status:  Prescription
Patent and Exclusivity Information

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