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CARDENE Drug Profile

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Cardene is a drug marketed by Chiesi Usa Inc and is included in three NDAs. It is available from three suppliers. There are four patents protecting this drug and five Paragraph IV challenges.

The generic ingredient in CARDENE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

Summary for Tradename: CARDENE

Patents:4
Applicants:1
NDAs:3
Suppliers / Packagers: see list3
Drug Prices: :see details

Pharmacology for Tradename: CARDENE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
INJECTABLE;INJECTION019734-001Jan 30, 1992RXYes► subscribe► subscribe
Chiesi Usa Inc
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
nicardipine hydrochloride
INJECTABLE;INTRAVENOUS019734-005Nov 7, 2008RXYes7,612,102► subscribeY ► subscribe
Chiesi Usa Inc
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
nicardipine hydrochloride
INJECTABLE;INTRAVENOUS019734-004Nov 7, 2008RXYes9,364,564► subscribeY ► subscribe
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Expired Patents for Tradename: CARDENE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
INJECTABLE;INJECTION019734-001Jan 30, 19923,985,758► subscribe
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
CAPSULE;ORAL019488-001Dec 21, 19883,985,758► subscribe
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
INJECTABLE;INJECTION019734-001Jan 30, 19925,164,405► subscribe
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Paragraph IV activity for: CARDENE

Drugname Dosage Strength RLD Submissiondate
nicardipine hydrochlorideInjection0.1 mg/mL, 200 mL and0.2mg/mL, 200 mLCardene 0.83% Sodium Chloride in plastic container6/20/2013
nicardipine hydrochlorideInjection0.1 mg/mL, 200 mL and0.2mg/mL, 200 mLCardene in 0.86% Sodium Chloride in plastic container6/20/2013
nicardipine hydrochlorideInjection0.1 mg/mL, 200 mL and0.2mg/mL, 200 mLCardene 0.83% Sodium Chloride in plastic6/20/2013
nicardipine hydrochlorideInjection0.1 mg/mL, 200 mL and0.2mg/mL, 200 mLCardene in 0.86% Sodium Chloride in plas6/20/2013
nicardipine hydrochlorideInjection2.5 mg/mL, 10 mL AmpoulesCardene12/27/2006
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