Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212994
Company: COMMAVE THERAP
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note
03/02/2021 ORIG-1 Approval Label (PDF)

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