NDC 66658-510

GAMIFANT

(emapalumab-lzsg)

GAMIFANT is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Swedish Orphan Biovitrum Ab (publ). The primary component is Emapalumab.

Product ID66658-510_5a77518a-477d-47fa-a0d4-ce986eb7e964
NDC66658-510
Product TypeHuman Prescription Drug
Proprietary NameGAMIFANT
Generic Name(emapalumab-lzsg)
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-06-26
Marketing CategoryBLA / BLA
Application NumberBLA761107
Labeler NameSwedish Orphan Biovitrum AB (publ)
Substance NameEMAPALUMAB
Active Ingredient Strength100 mg/20mL
Pharm ClassesInterferon gamma Blocker [EPC],Interferon gamma Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 66658-510-01

1 VIAL, SINGLE-USE in 1 CARTON (66658-510-01) > 20 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2020-06-26
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "GAMIFANT" or generic name "(emapalumab-lzsg)"

NDCBrand NameGeneric Name
66658-501GAMIFANT(emapalumab-lzsg)
66658-505GAMIFANT(emapalumab-lzsg)
66658-510GAMIFANT(emapalumab-lzsg)
72171-501GAMIFANT(emapalumab-lzsg)
72171-505GAMIFANT(emapalumab-lzsg)

Trademark Results [GAMIFANT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GAMIFANT
GAMIFANT
87283834 5505933 Live/Registered
EMACO SA
2016-12-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.