NDC 70121-1627

FYLNETRA

Pegfilgrastim

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 ID70121-1627_56c3c6dd-ecf2-48f4-b247-181d122e362a
NDC70121-1627
Product TypeHuman Prescription Drug
Proprietary NameFYLNETRA
Generic NamePegfilgrastim
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2022-05-31
Marketing CategoryBLA /
Application NumberBLA761084
Labeler NameAmneal Pharmaceuticals LLC
Substance NamePEGFILGRASTIM
Active Ingredient Strength6 mg/.6mL
Pharm ClassesGranulocyte Colony-Stimulating Factor [CS], Granulocyte-Macrophage Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70121-1627-1

1 SYRINGE in 1 CARTON (70121-1627-1) > .6 mL in 1 SYRINGE
Marketing Start Date2022-05-31
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "FYLNETRA" or generic name "Pegfilgrastim"

NDCBrand NameGeneric Name
70121-1627FYLNETRApegfilgrastim
67457-833Fulphilapegfilgrastim
55513-190Neulastapegfilgrastim
55513-192Neulastapegfilgrastim

Trademark Results [FYLNETRA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FYLNETRA
FYLNETRA
97342227 not registered Live/Pending
KASHIV BIOSCIENCES, LLC
2022-04-01
FYLNETRA
FYLNETRA
88126983 not registered Live/Pending
Adello Biologics, LLC
2018-09-21

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