NDC 10122-502

Revcovi

Elapegademase-lvlr

Revcovi is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Chiesi Usa, Inc.. The primary component is Elapegademase.

Product ID10122-502_4404cb41-0794-4af5-848e-163017ab951b
NDC10122-502
Product TypeHuman Prescription Drug
Proprietary NameRevcovi
Generic NameElapegademase-lvlr
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2018-10-05
Marketing CategoryBLA /
Application NumberBLA761092
Labeler NameChiesi USA, Inc.
Substance NameELAPEGADEMASE
Active Ingredient Strength2 mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 10122-502-01

1 VIAL in 1 CARTON (10122-502-01) > 1.5 mL in 1 VIAL
Marketing Start Date2018-10-05
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Revcovi" or generic name "Elapegademase-lvlr"

NDCBrand NameGeneric Name
10122-502Revcovielapegademase-lvlr
57665-002Revcovielapegademase-lvlr

Trademark Results [Revcovi]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REVCOVI
REVCOVI
87300981 5800819 Live/Registered
LEADIANT BIOSCIENCES LIMITED
2017-01-13

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