Orange Book product · Generic (ANDA)
NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE
At a glance
Apr 10, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 10, 2024
2 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
NICARDIPINE HYDROCHLORIDE
Strength
20MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 218202
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 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.
