Details for New Drug Application (NDA): 019734

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NDA 019734 describes CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, which is a drug marketed by Chiesi and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER profile page.

The generic ingredient in CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

Summary for 019734

Tradename:	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
Applicant:	Chiesi
Ingredient:	nicardipine hydrochloride
Patents:	6

Pharmacology for NDA: 019734

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for 019734

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 019734

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734	NDA	Baxter Healthcare Corporation	43066-009	43066-009-10	10 BAG in 1 CARTON (43066-009-10) / 200 mL in 1 BAG
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734	NDA	Baxter Healthcare Corporation	43066-009	43066-009-10	10 BAG in 1 CARTON (43066-009-10) / 200 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 30, 1992	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	20MG/200ML (0.1MG/ML)
Approval Date:	Jul 31, 2008	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Apr 18, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Apr 18, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED THEREOF

Expired US Patents for NDA 019734

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	⤷ Sign Up	⤷ Sign Up
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	⤷ Sign Up	⤷ Sign Up
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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