Orange Book product · Generic (ANDA)
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
NICARDIPINE HYDROCHLORIDE
At a glance
Apr 17, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 17, 2024
2 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
NICARDIPINE HYDROCHLORIDE
Strength
40MG/200ML (0.2MG/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
ANDA 203978
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NICARDIPINE HYDROCHLORIDE
- 2009NICARDIPINE HYDROCHLORIDEBrand (NDA)
NDA 078405 · SUN PHARM
- 2008NICARDIPINE HYDROCHLORIDEBrand (NDA)
NDA 022276 · HIKMA INTL PHARMS
- 1992CARDENE SRBrand (NDA)
NDA 020005 · CHIESI
- 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
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.
