Orange Book product · Brand (NDA)
BUMEX
BUMETANIDE
At a glance
Feb 28, 1983
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 28, 1983
43 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BUMETANIDE
Strength
0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 018226
Product number
001
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.
- 2025ENBUMYSTBrand (NDA)
NDA 219500 · CORSTASIS THERAP
- 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
- 2025BUMETANIDEGeneric (ANDA)
ANDA 218746 · ASPIRO
- 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.
