NDC 0002-3115

EMGALITY

Galcanezumab-gnlm

EMGALITY is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Galcanezumab.

Product ID0002-3115_4b767820-97fe-430d-8e77-6047e82ac81e
NDC0002-3115
Product TypeHuman Prescription Drug
Proprietary NameEMGALITY
Generic NameGalcanezumab-gnlm
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-06-04
Marketing CategoryBLA / BLA
Application NumberBLA761063
Labeler NameEli Lilly and Company
Substance NameGALCANEZUMAB
Active Ingredient Strength100 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0002-3115-09

3 SYRINGE in 1 CARTON (0002-3115-09) > 1 mL in 1 SYRINGE (0002-3115-01)
Marketing Start Date2019-06-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0002-3115-09 [00002311509]

EMGALITY INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761063
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-17

NDC 0002-3115-01 [00002311501]

EMGALITY INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761063
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-04

Drug Details

Active Ingredients

IngredientStrength
GALCANEZUMAB100 mg/mL

NDC Crossover Matching brand name "EMGALITY" or generic name "Galcanezumab-gnlm"

NDCBrand NameGeneric Name
0002-1436EMGALITYgalcanezumab-gnlm
0002-2377EMGALITYgalcanezumab-gnlm
0002-3115EMGALITYgalcanezumab-gnlm

Trademark Results [EMGALITY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EMGALITY
EMGALITY
88112647 not registered Live/Pending
Eli Lilly and Company
2018-09-11
EMGALITY
EMGALITY
87435081 5633683 Live/Registered
Eli Lilly and Company
2017-05-03
EMGALITY
EMGALITY
87263356 5628446 Live/Registered
Eli Lilly and Company
2016-12-09

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