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Last Updated: November 2, 2024

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 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-two 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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Dec 21, 1988TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Dec 21, 1988TE:RLD:Yes

Expired US Patents for NDA 019488

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

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