Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 212994
Company: COMMAVE THERAP
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 |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note |
---|---|---|---|---|
10/13/2023 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
10/13/2023 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note |
---|---|---|---|---|
10/13/2023 | SUPPL-7 | Labeling-Medication Guide | Label (PDF) | |
10/13/2023 | SUPPL-7 | Labeling-Package Insert | 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) |