Orange Book product · Brand (NDA)
GVOKE VIALDX
GLUCAGON
At a glance
Mar 14, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 14, 2025
1 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
GLUCAGON
Strength
1MG/0.2ML (1MG/0.2ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 212097
Product number
006
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2019BAQSIMIBrand (NDA)
NDA 210134 · AMPHASTAR PHARMS INC
- 1998GLUCAGONBrand (NDA)
NDA 020928 · LILLY
- 2025GLUCAGONGeneric (ANDA)
ANDA 218813 · CIPLA
- 2025GLUCAGONGeneric (ANDA)
ANDA 214457 · LUPIN
- 2024GLUCAGONGeneric (ANDA)
ANDA 204468 · MYLAN LABS LTD
- 2020GLUCAGONGeneric (ANDA)
ANDA 208086 · AMPHASTAR PHARMS INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
