Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215904
Company: MARINUS
Company: MARINUS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZTALMY | GANAXOLONE | 50MG/ML | SUSPENSION;ORAL | Prescription | TBD | 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 |
|---|---|---|---|---|---|---|
| 03/18/2022 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Federal Register Notice (PDF)
Label (PDF) Letter (PDF) Review |
Date of Approval; FR Notice on DEA Scheduling. Approval Date: June 1, 2022 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note |
|---|---|---|---|---|
| 03/18/2022 | ORIG-1 | Approval | Label (PDF) |
ZTALMY
There are no Therapeutic Equivalents.
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