FYLNETRA is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Pegfilgrastim.
Product ID | 70121-1627_56c3c6dd-ecf2-48f4-b247-181d122e362a |
NDC | 70121-1627 |
Product Type | Human Prescription Drug |
Proprietary Name | FYLNETRA |
Generic Name | Pegfilgrastim |
Dosage Form | Injection |
Route of Administration | SUBCUTANEOUS |
Marketing Start Date | 2022-05-31 |
Marketing Category | BLA / |
Application Number | BLA761084 |
Labeler Name | Amneal Pharmaceuticals LLC |
Substance Name | PEGFILGRASTIM |
Active Ingredient Strength | 6 mg/.6mL |
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 | 2022-05-31 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
70121-1627 | FYLNETRA | pegfilgrastim |
67457-833 | Fulphila | pegfilgrastim |
55513-190 | Neulasta | pegfilgrastim |
55513-192 | Neulasta | pegfilgrastim |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FYLNETRA 97342227 not registered Live/Pending |
KASHIV BIOSCIENCES, LLC 2022-04-01 |
FYLNETRA 88126983 not registered Live/Pending |
Adello Biologics, LLC 2018-09-21 |