Last Updated: August 11, 2026

Details for New Drug Application (NDA): 019488

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NDA 019488 describes CARDENE, which is a drug marketed by Chiesi and is included in three NDAs. It is available from one supplier. There are six patents protecting this drug and five Paragraph IV challenges. Additional details are available on the CARDENE profile page.

The generic ingredient in CARDENE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

Summary for 019488

Tradename:	CARDENE
Applicant:	Chiesi
Ingredient:	nicardipine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 019488

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 21, 1988	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 21, 1988	TE:		RLD:	Yes

Expired US Patents for NDA 019488

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-001	Dec 21, 1988	3,985,758	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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