Orange Book product · Generic (ANDA)
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
NICARDIPINE HYDROCHLORIDE
At a glance
Sep 24, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 24, 2024
1 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
NICARDIPINE HYDROCHLORIDE
Strength
20MG/200ML (0.1MG/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
ANDA 215592
Product number
001
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 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.
