Orange Book product · Generic (ANDA)
BUMETANIDE
BUMETANIDE
At a glance
Feb 27, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 27, 2025
1 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
BUMETANIDE
Strength
0.25MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 218746
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BUMETANIDE
- 2025ENBUMYSTBrand (NDA)
NDA 219500 · CORSTASIS THERAP
- 1983BUMEXBrand (NDA)
NDA 018226 · VALIDUS PHARMS
- 1983BUMEXBrand (NDA)
NDA 018225 · VALIDUS PHARMS
- 2026BUMETANIDEGeneric (ANDA)
ANDA 220427 · ANTHEA PHARMA
- 2026BUMETANIDEGeneric (ANDA)
ANDA 215362 · MSN
- 2025BUMETANIDEGeneric (ANDA)
ANDA 212470 · JUBILANT GENERICS
- 2025BUMETANIDEGeneric (ANDA)
ANDA 219291 · MANKIND PHARMA
- 2024BUMETANIDEGeneric (ANDA)
ANDA 213942 · RUBICON RESEARCH
- 2024BUMETANIDEGeneric (ANDA)
ANDA 219116 · QILU PHARM HAINAN
- 2024BUMETANIDEGeneric (ANDA)
ANDA 212931 · APPCO
- 2024BUMETANIDEGeneric (ANDA)
ANDA 217153 · LUPIN
- 2023BUMETANIDEGeneric (ANDA)
ANDA 213458 · TARO
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.
