Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212994

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AZSTARYS (DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE)
EQ 5.2MG BASE;EQ 26.1MG BASE
Marketing Status: Prescription

Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
Proprietary Name: AZSTARYS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 5.2MG BASE;EQ 26.1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212994
Product Number: 001
Approval Date: May 7, 2021
Applicant Holder Full Name: COMMAVE THERAPEUTICS SA
Marketing Status:  Prescription
Patent and Exclusivity Information

AZSTARYS (DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE)
EQ 7.8MG BASE;EQ 39.2MG BASE
Marketing Status: Prescription

Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
Proprietary Name: AZSTARYS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 7.8MG BASE;EQ 39.2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212994
Product Number: 002
Approval Date: May 7, 2021
Applicant Holder Full Name: COMMAVE THERAPEUTICS SA
Marketing Status:  Prescription
Patent and Exclusivity Information

AZSTARYS (DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE)
EQ 10.4MG BASE;EQ 52.3MG BASE
Marketing Status: Prescription

Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
Proprietary Name: AZSTARYS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10.4MG BASE;EQ 52.3MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212994
Product Number: 003
Approval Date: May 7, 2021
Applicant Holder Full Name: COMMAVE THERAPEUTICS SA
Marketing Status:  Prescription
Patent and Exclusivity Information