ZTALMY is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Marinus Pharmaceuticals, Inc.. The primary component is Ganaxolone.
Product ID | 81583-100_76fb746f-e81a-49b8-aac7-b80f7900c654 |
NDC | 81583-100 |
Product Type | Human Prescription Drug |
Proprietary Name | ZTALMY |
Generic Name | Ganaxolone |
Dosage Form | Suspension |
Route of Administration | ORAL |
Marketing Start Date | 2022-06-06 |
Marketing Category | NDA / |
Application Number | NDA215904 |
Labeler Name | Marinus Pharmaceuticals, Inc. |
Substance Name | GANAXOLONE |
Active Ingredient Strength | 50 mg/mL |
DEA Schedule | CV |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2022-06-06 |
NDC Exclude Flag | N |
Sample Package? | N |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZTALMY 90046102 not registered Live/Pending |
Marinus Pharmaceuticals, Inc. 2020-07-10 |