RELEUKO is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Filgrastim.
Product ID | 70121-1569_0b7683ae-91e8-44b0-84a6-e185b84b5664 |
NDC | 70121-1569 |
Product Type | Human Prescription Drug |
Proprietary Name | RELEUKO |
Generic Name | Filgrastim |
Dosage Form | Injection, Solution |
Route of Administration | INTRAVENOUS; SUBCUTANEOUS |
Marketing Start Date | 2022-02-25 |
Marketing Category | BLA / |
Application Number | BLA761082 |
Labeler Name | Amneal Pharmaceuticals LLC |
Substance Name | FILGRASTIM |
Active Ingredient Strength | 300 ug/mL |
Pharm Classes | Granulocyte Colony-Stimulating Factor [CS], Granulocyte-Macrophage Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2022-02-25 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
70121-1568 | RELEUKO | Filgrastim |
70121-1569 | RELEUKO | Filgrastim |
70121-1570 | RELEUKO | Filgrastim |
70121-1571 | RELEUKO | Filgrastim |
55513-209 | NEUPOGEN | Filgrastim |
55513-530 | NEUPOGEN | Filgrastim |
55513-546 | NEUPOGEN | Filgrastim |
55513-924 | NEUPOGEN | Filgrastim |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RELEUKO 90567963 not registered Live/Pending |
KASHIV BIOSCIENCES, LLC 2021-03-09 |
RELEUKO 87594432 not registered Live/Pending |
Adello Biologics, LLC 2017-09-01 |