Orange Book product · Brand (NDA)
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
NICARDIPINE HYDROCHLORIDE
At a glance
Jul 31, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 31, 2008
18 yr 2 mo ago
Today
Patent 10758616 expires
Listed drug product patent expiration.
Apr 18, 2027
in 10 mo
Patent 11547758 expires
Listed method-of-use patent (U-1029) expiration.
Apr 18, 2027
in 10 mo
Patent 7659291 expires
Listed method-of-use patent (U-1029) expiration.
Apr 18, 2027
in 10 mo
Patent 8455524 expires
Listed method-of-use patent (U-1029) expiration.
Apr 18, 2027
in 10 mo
Patent 7612102 expires
Listed drug product patent expiration.
Dec 26, 2027
in 1 yr 7 mo
Patent 9364564 expires
Listed drug product patent expiration.
Dec 26, 2027
in 1 yr 7 mo
Pharmaceutical detail
Active ingredient
NICARDIPINE HYDROCHLORIDE
Strength
20MG/200ML (0.1MG/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 019734
Product number
002
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.
- 2009NICARDIPINE HYDROCHLORIDEBrand (NDA)
NDA 078405 · SUN PHARM
- 2008NICARDIPINE HYDROCHLORIDEBrand (NDA)
NDA 022276 · HIKMA INTL PHARMS
- 1992CARDENE SRBrand (NDA)
NDA 020005 · 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 (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10758616 | Apr 18, 2027 | in 10 mo | Product |
| 11547758 | Apr 18, 2027 | in 10 mo | U-1029 |
| 7659291 | Apr 18, 2027 | in 10 mo | U-1029 |
| 8455524 | Apr 18, 2027 | in 10 mo | U-1029 |
| 7612102 | Dec 26, 2027 | in 1 yr 7 mo | Product |
| 9364564 | Dec 26, 2027 | in 1 yr 7 mo | Product |
