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. Eleven 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:	5
Formulation / Manufacturing:	see details

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		Strength	25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	See Plans and Pricing	Patent Expiration:	Apr 18, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	See Plans and Pricing	Patent Expiration:	Dec 26, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

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	See Plans and Pricing	See Plans and Pricing
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	See Plans and Pricing	See Plans and Pricing
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.