Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018735

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

Active Ingredient: IOPAMIDOL
Proprietary Name: ISOVUE-200
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 41%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP2
Application Number: N018735
Product Number: 006
Approval Date: Jul 7, 1987
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: IOPAMIDOL
Proprietary Name: ISOVUE-250
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 51%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N018735
Product Number: 007
Approval Date: Jul 6, 1992
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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: AP
Application Number: N018735
Product Number: 002
Approval Date: Dec 31, 1985
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: AP
Application Number: N018735
Product Number: 003
Approval Date: Dec 31, 1985
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ISOVUE-M 200 (IOPAMIDOL)
41%
Marketing Status: Prescription

Active Ingredient: IOPAMIDOL
Proprietary Name: ISOVUE-M 200
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 41%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP1
Application Number: N018735
Product Number: 001
Approval Date: Dec 31, 1985
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: IOPAMIDOL
Proprietary Name: ISOVUE-M 300
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 61%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N018735
Product Number: 004
Approval Date: Dec 31, 1985
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ISOVUE-128 (IOPAMIDOL)
26%
Marketing Status: Discontinued

Active Ingredient: IOPAMIDOL
Proprietary Name: ISOVUE-128
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 26%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018735
Product Number: 005
Approval Date: Oct 21, 1986
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information