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 |