Orange Book product · Brand (NDA)
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
NICARDIPINE HYDROCHLORIDE
At a glance
Nov 07, 2008
Approved
Brand (NDA)
Application
AP
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 07, 2008
17 yr 10 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
40MG/200ML (0.2MG/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
NDA 019734
Product number
004
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 |
