Orange Book product · Generic (ANDA)
GLUCAGON
GLUCAGON
At a glance
Sep 15, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 15, 2025
9 mo ago
Exclusivity ends · CGT
FDA marketing exclusivity
Apr 18, 2026
2 mo ago
Today
Pharmaceutical detail
Active ingredient
GLUCAGON
Strength
1MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 218813
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GLUCAGON
- 2025GVOKE VIALDXBrand (NDA)
NDA 212097 · XERIS
- 2019BAQSIMIBrand (NDA)
NDA 210134 · AMPHASTAR PHARMS INC
- 1998GLUCAGONBrand (NDA)
NDA 020928 · LILLY
- 2025GLUCAGONGeneric (ANDA)
ANDA 214457 · LUPIN
- 2024GLUCAGONGeneric (ANDA)
ANDA 204468 · MYLAN LABS LTD
- 2020GLUCAGONGeneric (ANDA)
ANDA 208086 · AMPHASTAR PHARMS INC
Marketing exclusivity (1)
- CGTFDA marketing exclusivity
Apr 18, 2026
2 mo ago
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.
