XYWAV is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is Sodium Oxybate; Calcium Oxybate; Potassium Oxybate; Magnesium Oxybate.
Product ID | 68727-150_128ed05a-6bef-4f3e-a6a6-3e88f04aa86c |
NDC | 68727-150 |
Product Type | Human Prescription Drug |
Proprietary Name | XYWAV |
Generic Name | (calcium, Magnesium, Potassium, And Sodium Oxybates) |
Dosage Form | Solution |
Route of Administration | ORAL |
Marketing Start Date | 2020-11-02 |
Marketing Category | NDA / NDA |
Application Number | NDA212690 |
Labeler Name | Jazz Pharmaceuticals, Inc. |
Substance Name | SODIUM OXYBATE; CALCIUM OXYBATE; POTASSIUM OXYBATE; MAGNESIUM OXYBATE |
Active Ingredient Strength | 1 g/mL; g/mL; g/mL; g/mL |
Pharm Classes | Central Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE],Central Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE],Central Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE],Central Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE] |
DEA Schedule | CIII |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2020-11-02 |
NDC Exclude Flag | N |
Sample Package? | N |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
XYWAV 88546670 not registered Live/Pending |
Jazz Pharmaceuticals, Inc. 2019-07-29 |