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Last Updated: July 4, 2020

DrugPatentWatch Database Preview

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. Nine 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:4
Formulation / Manufacturing:see details
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 Chiesi USA, Inc. 10122-313 10122-313-10 10 CARTON in 1 BOX (10122-313-10) > 1 BAG in 1 CARTON (10122-313-01) > 200 mL in 1 BAG
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734 NDA Chiesi USA, Inc. 10122-313 10122-313-10 10 CARTON in 1 BOX (10122-313-10) > 1 BAG in 1 CARTON (10122-313-01) > 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(2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:  Start TrialPatent Expiration:Dec 26, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent 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   Start Trial   Start Trial
Chiesi CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992   Start Trial   Start Trial
Chiesi CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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