AKYNZEO is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Helsinn Therapeutics (u.s.), Inc.. The primary component is Fosnetupitant; Palonosetron Hydrochloride.
Product ID | 69639-105_7c25ad52-d737-489f-b229-1e2a6fa0add1 |
NDC | 69639-105 |
Product Type | Human Prescription Drug |
Proprietary Name | AKYNZEO |
Generic Name | Fosnetupitant And Palonosetron |
Dosage Form | Injection |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2020-06-15 |
Marketing Category | NDA / NDA |
Application Number | NDA210493 |
Labeler Name | Helsinn Therapeutics (U.S.), Inc. |
Substance Name | FOSNETUPITANT; PALONOSETRON HYDROCHLORIDE |
Active Ingredient Strength | 260 mg/20mL; mg/20mL |
Pharm Classes | Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2020-06-15 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
69639-101 | AKYNZEO | Netupitant and Palonosetron |
69639-102 | AKYNZEO | Fosnetupitant and Palonosetron |
69639-105 | AKYNZEO | Fosnetupitant and Palonosetron |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AKYNZEO 85264083 4066299 Live/Registered |
Helsinn Healthcare S.A. 2011-03-11 |
AKYNZEO 79140820 4595036 Live/Registered |
Helsinn Healthcare SA 2013-10-17 |