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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019734

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CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE)
40MG/200ML (0.2MG/ML)
Marketing Status: Prescription
Active Ingredient: NICARDIPINE HYDROCHLORIDE
Proprietary Name: CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 40MG/200ML (0.2MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019734
Product Number: 004
Approval Date: Nov 7, 2008
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE)
20MG/200ML (0.1MG/ML)
Marketing Status: Prescription
Active Ingredient: NICARDIPINE HYDROCHLORIDE
Proprietary Name: CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 20MG/200ML (0.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019734
Product Number: 003
Approval Date: Jul 31, 2008
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE)
20MG/200ML (0.1MG/ML)
Marketing Status: Prescription
Active Ingredient: NICARDIPINE HYDROCHLORIDE
Proprietary Name: CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 20MG/200ML (0.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N019734
Product Number: 002
Approval Date: Jul 31, 2008
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
CARDENE (NICARDIPINE HYDROCHLORIDE)
25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NICARDIPINE HYDROCHLORIDE
Proprietary Name: CARDENE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019734
Product Number: 001
Approval Date: Jan 30, 1992
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE)
40MG/200ML (0.2MG/ML)
Marketing Status: Discontinued
Active Ingredient: NICARDIPINE HYDROCHLORIDE
Proprietary Name: CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 40MG/200ML (0.2MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019734
Product Number: 005
Approval Date: Nov 7, 2008
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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