Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212994
Company: COMMAVE THERAP

• Medication Guide

Products on NDA 212994

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZSTARYS	DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
AZSTARYS	DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
AZSTARYS	DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212994

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
03/02/2021	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	STANDARD	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice on DEA Scheduling; Date of Approval – May 7, 2021

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
10/13/2023	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)
10/13/2023	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)

Labels for NDA 212994

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
10/13/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)
10/13/2023	SUPPL-7	Labeling-Medication Guide	Label (PDF)
10/13/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)
10/13/2023	SUPPL-4	Labeling-Medication Guide	Label (PDF)
03/02/2021	ORIG-1	Approval	Label (PDF)