Orange Book product · Generic (ANDA)
SPIRONOLACTONE
SPIRONOLACTONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
SPIRONOLACTONE
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 087265
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SPIRONOLACTONE
- 2017CAROSPIRBrand (NDA)
NDA 209478 · CMP DEV LLC
- 1983ALDACTONEBrand (NDA)
NDA 012151 · PFIZER
- 2025SPIRONOLACTONEGeneric (ANDA)
ANDA 217761 · ANNORA PHARMA
- 2025SPIRONOLACTONEGeneric (ANDA)
ANDA 218085 · HETERO LABS LTD III
- 2025SPIRONOLACTONEGeneric (ANDA)
ANDA 219494 · GRAVITI PHARMS
- 2023SPIRONOLACTONEGeneric (ANDA)
ANDA 215572 · AMNEAL
- 2018SPIRONOLACTONEGeneric (ANDA)
ANDA 205936 · ZYDUS PHARMS
- 2016SPIRONOLACTONEGeneric (ANDA)
ANDA 203512 · ACCORD HLTHCARE
- 2014SPIRONOLACTONEGeneric (ANDA)
ANDA 203253 · JUBILANT GENERICS
- 2014SPIRONOLACTONEGeneric (ANDA)
ANDA 202187 · AUROBINDO PHARMA
- 2010SPIRONOLACTONEGeneric (ANDA)
ANDA 091426 · AMNEAL PHARMS
- 2006SPIRONOLACTONEGeneric (ANDA)
ANDA 040750 · OXFORD PHARMS
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.
