Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022156

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CLEVIPREX (CLEVIDIPINE)
25MG/50ML (0.5MG/ML)
Marketing Status: Prescription

Active Ingredient: CLEVIDIPINE
Proprietary Name: CLEVIPREX
Dosage Form; Route of Administration: EMULSION; INTRAVENOUS
Strength: 25MG/50ML (0.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022156
Product Number: 001
Approval Date: Aug 1, 2008
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CLEVIPREX (CLEVIDIPINE)
50MG/100ML (0.5MG/ML)
Marketing Status: Prescription

Active Ingredient: CLEVIDIPINE
Proprietary Name: CLEVIPREX
Dosage Form; Route of Administration: EMULSION; INTRAVENOUS
Strength: 50MG/100ML (0.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022156
Product Number: 002
Approval Date: Aug 1, 2008
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CLEVIPREX (CLEVIDIPINE)
125MG/250ML (0.5MG/ML)
Marketing Status: Discontinued

Active Ingredient: CLEVIDIPINE
Proprietary Name: CLEVIPREX
Dosage Form; Route of Administration: EMULSION; INTRAVENOUS
Strength: 125MG/250ML (0.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022156
Product Number: 003
Approval Date: Nov 8, 2013
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information