Orange Book product · Brand (NDA)
CARDENE SR
NICARDIPINE HYDROCHLORIDE
At a glance
Feb 21, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 21, 1992
34 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
NICARDIPINE HYDROCHLORIDE
Strength
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 020005
Product number
003
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.
- 2009NICARDIPINE HYDROCHLORIDEBrand (NDA)
NDA 078405 · SUN PHARM
- 2008NICARDIPINE HYDROCHLORIDEBrand (NDA)
NDA 022276 · HIKMA INTL PHARMS
- 1992CARDENEBrand (NDA)
NDA 019734 · CHIESI
- 1988CARDENEBrand (NDA)
NDA 019488 · CHIESI
- 2025NICARDIPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219608 · QILU PHARM HAINAN
- 2025NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEGeneric (ANDA)
ANDA 220243 · CAPLIN
- 2025NICARDIPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216819 · NANJING KING FRIEND
- 2025NICARDIPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218638 · NAVINTA LLC
- 2024NICARDIPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215406 · AMNEAL
- 2024NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEGeneric (ANDA)
ANDA 215592 · CIPLA
- 2024NICARDIPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217548 · CHENGDU SHUODE
- 2024NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDEGeneric (ANDA)
ANDA 203978 · INFORLIFE
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.
