Application 019734

Type: NDA
Sponsor: CHIESI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDENE	NICARDIPINE HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	20MG/200ML (0.1MG/ML)	Yes	Yes
003	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	20MG/200ML (0.1MG/ML)	Yes	Yes
004	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	40MG/200ML (0.2MG/ML)	Yes	Yes
005	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	40MG/200ML (0.2MG/ML)	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10122-313	Cardene IV	nicardipine hydrochloride	Chiesi USA, Inc.	NDA	Current
10122-313	Cardene IV	nicardipine hydrochloride	Chiesi USA, Inc.	NDA	Current
10122-314	Cardene IV	nicardipine hydrochloride	Chiesi USA, Inc.	NDA	Current
10122-314	Cardene IV	nicardipine hydrochloride	Chiesi USA, Inc.	NDA	Current
10122-325	Cardene IV	nicardipine hydrochloride	Chiesi USA, Inc.	NDA	Current
10122-325	Cardene IV	nicardipine hydrochloride	Chiesi USA, Inc.	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-009	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-016	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-021	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-021	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-021	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-021	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-021	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-024	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-024	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-024	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-024	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-024	Cardene IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-026	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-026	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-026	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-026	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-026	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-026	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-028	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-028	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-028	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-028	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-028	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-028	CARDENE IV	nicardipine hydrochloride	Baxter Healthcare Corporation	NDA	Current
51662-1428	NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85594	SUPPL	2026-03-31
85577	SUPPL	2026-03-30
81367	SUPPL	2025-02-25
81354	SUPPL	2025-02-25
72132	SUPPL	2022-09-21
72104	SUPPL	2022-09-19
57353	SUPPL	2019-01-28
55048	SUPPL	2018-07-30
45172	SUPPL	2016-08-26
45068	SUPPL	2016-08-26
11665	SUPPL	2014-07-24
1559	SUPPL	2014-07-24
1558	SUPPL	2011-02-09
33895	SUPPL	2011-02-07
33894	SUPPL	2010-01-20
19133	SUPPL	2010-01-15
1557	SUPPL	2008-11-13
62317	SUPPL	2008-11-07
1556	SUPPL	2008-08-05
62316	SUPPL	2008-07-31
19132	SUPPL	2007-07-05

Application 019734

Related Records#

Application Products#

NDC Listings For This Application#

Documents#