← FDA DRUG APPROVALS

FDA NDA · NDA212994

AZSTARYS

serdexmethylphenidate and dexmethylphenidate

Sponsor: COMMAVE SUB

APPLICATION
NDA212994
TYPE
NDA
ORIGINAL APPROVAL
2021-03-02
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

AZSTARYS · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE EQ 7.8MG BASE, SERDEXMETHYLPHENIDATE CHLORIDE EQ 39.2MG BASE · CAPSULE · ORAL
AZSTARYS · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE EQ 10.4MG BASE, SERDEXMETHYLPHENIDATE CHLORIDE EQ 52.3MG BASE · CAPSULE · ORAL
AZSTARYS · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE EQ 5.2MG BASE, SERDEXMETHYLPHENIDATE CHLORIDE EQ 26.1MG BASE · CAPSULE · ORAL

Approval history

2025-09-23Labeling · Supplement 12 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 4 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 7 · standard — Letter ↗AP
2021-03-02Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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