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Generated: November 18, 2018

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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 Usa Inc and is included in one NDA. It is available from one supplier. 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. Twelve 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 Usa Inc
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)
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:Dec 26, 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 Usa Inc CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 ➤ Sign Up ➤ Sign Up
Chiesi Usa Inc CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 ➤ Sign Up ➤ Sign Up
Chiesi Usa Inc 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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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
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Daiichi Sankyo
Healthtrust
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Covington
Express Scripts

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