Details for New Drug Application (NDA): 019488

✉ Email this page to a colleague

NDA 019488 describes CARDENE, which is a drug marketed by Chiesi and is included in three NDAs. It is available from two suppliers. 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. Twenty-five 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DISCN	Dosage:	CAPSULE;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-001	Dec 21, 1988	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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.