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 |