Orange Book product · Brand (NDA)
ALDACTONE
SPIRONOLACTONE
At a glance
Dec 30, 1983
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 30, 1983
43 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
SPIRONOLACTONE
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 012151
Product number
009
Marketing status
RX
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.
- 2017CAROSPIRBrand (NDA)
NDA 209478 · CMP DEV LLC
- 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
- 2006SPIRONOLACTONEGeneric (ANDA)
ANDA 040353 · ACTAVIS ELIZABETH
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.
