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Last Updated: November 24, 2024

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-four suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 019734
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:DISCNDosage:INJECTABLE;INJECTIONStrength25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 30, 1992TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength20MG/200ML (0.1MG/ML)
Approval Date:Jul 31, 2008TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 18, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Apr 18, 2027Product 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

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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