Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020327

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ISOVUE-300 (IOPAMIDOL)
61%
Marketing Status: Prescription

Active Ingredient: IOPAMIDOL
Proprietary Name: ISOVUE-300
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 61%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020327
Product Number: 003
Approval Date: Oct 12, 1994
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ISOVUE-370 (IOPAMIDOL)
76%
Marketing Status: Prescription

Active Ingredient: IOPAMIDOL
Proprietary Name: ISOVUE-370
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 76%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020327
Product Number: 004
Approval Date: Oct 12, 1994
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ISOVUE-200 (IOPAMIDOL)
41%
Marketing Status: Discontinued

Active Ingredient: IOPAMIDOL
Proprietary Name: ISOVUE-200
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 41%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020327
Product Number: 001
Approval Date: Oct 12, 1994
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ISOVUE-250 (IOPAMIDOL)
51%
Marketing Status: Discontinued

Active Ingredient: IOPAMIDOL
Proprietary Name: ISOVUE-250
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 51%
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020327
Product Number: 002
Approval Date: Oct 12, 1994
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information