NDC 47783-646

TAKHZYRO

Lanadelumab-flyo

TAKHZYRO is a Subcutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Lanadelumab.

Product ID47783-646_b9f42ab3-57b5-4789-a4d9-ac1e11cb120d
NDC47783-646
Product TypeHuman Prescription Drug
Proprietary NameTAKHZYRO
Generic NameLanadelumab-flyo
Dosage FormSolution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2022-02-08
Marketing CategoryBLA /
Application NumberBLA761090
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameLANADELUMAB
Active Ingredient Strength300 mg/2mL
Pharm ClassesKallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 47783-646-01

1 SYRINGE, GLASS in 1 CARTON (47783-646-01) > 2 mL in 1 SYRINGE, GLASS
Marketing Start Date2022-02-08
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "TAKHZYRO" or generic name "Lanadelumab-flyo"

NDCBrand NameGeneric Name
47783-644TAKHZYROlanadelumab-flyo
47783-646TAKHZYROlanadelumab-flyo

Trademark Results [TAKHZYRO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TAKHZYRO
TAKHZYRO
87738368 not registered Live/Pending
Dyax Corp.
2017-12-29

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