Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020608

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OMNIPAQUE 350 (IOHEXOL)
75.5%
Marketing Status: Prescription

Active Ingredient: IOHEXOL
Proprietary Name: OMNIPAQUE 350
Dosage Form; Route of Administration: SOLUTION; INJECTION, ORAL
Strength: 75.5%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020608
Product Number: 003
Approval Date: Oct 24, 1995
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information

OMNIPAQUE 300 (IOHEXOL)
64.7%
Marketing Status: Prescription

Active Ingredient: IOHEXOL
Proprietary Name: OMNIPAQUE 300
Dosage Form; Route of Administration: SOLUTION; INJECTION, ORAL, RECTAL
Strength: 64.7%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020608
Product Number: 002
Approval Date: Oct 24, 1995
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information

OMNIPAQUE 240 (IOHEXOL)
51.8%
Marketing Status: Discontinued

Active Ingredient: IOHEXOL
Proprietary Name: OMNIPAQUE 240
Dosage Form; Route of Administration: SOLUTION; INJECTION, ORAL, RECTAL
Strength: 51.8%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020608
Product Number: 001
Approval Date: Oct 24, 1995
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information