Orange Book product · Brand (NDA)
CAROSPIR
SPIRONOLACTONE
At a glance
Aug 04, 2017
Approved
Brand (NDA)
Application
AB
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 04, 2017
9 yr ago
Today
Patent 10493083 expires
Listed drug product patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 10624906 expires
Listed drug product patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 10660907 expires
Listed drug product patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 10888570 expires
Listed drug product patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 11389461 expires
Listed drug product patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 11395828 expires
Listed method-of-use patent (U-2109) expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 11395828 expires
Listed method-of-use patent (U-3401) expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 11395828 expires
Listed method-of-use patent (U-3402) expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 11491166 expires
Listed drug product patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 9757394 expires
Listed drug product patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Pharmaceutical detail
Active ingredient
SPIRONOLACTONE
Strength
25MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 209478
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 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
- 2006SPIRONOLACTONEGeneric (ANDA)
ANDA 040353 · ACTAVIS ELIZABETH
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10493083 | Oct 28, 2036 | in 10 yr 6 mo | Product |
| 10624906 | Oct 28, 2036 | in 10 yr 6 mo | Product |
| 10660907 | Oct 28, 2036 | in 10 yr 6 mo | Product |
| 10888570 | Oct 28, 2036 | in 10 yr 6 mo | Product |
| 11389461 | Oct 28, 2036 | in 10 yr 6 mo | Product |
| 11395828 | Oct 28, 2036 | in 10 yr 6 mo | U-2109 |
| 11395828 | Oct 28, 2036 | in 10 yr 6 mo | U-3401 |
| 11395828 | Oct 28, 2036 | in 10 yr 6 mo | U-3402 |
| 11491166 | Oct 28, 2036 | in 10 yr 6 mo | Product |
| 9757394 | Oct 28, 2036 | in 10 yr 6 mo | ProductU-2109 |
