Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018956

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OMNIPAQUE 140 (IOHEXOL)
30.2%
Marketing Status: Prescription

Active Ingredient: IOHEXOL
Proprietary Name: OMNIPAQUE 140
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 30.2%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018956
Product Number: 005
Approval Date: Nov 30, 1988
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information

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: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018956
Product Number: 004
Approval Date: Dec 26, 1985
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information

OMNIPAQUE 180 (IOHEXOL)
38.8%
Marketing Status: Prescription

Active Ingredient: IOHEXOL
Proprietary Name: OMNIPAQUE 180
Dosage Form; Route of Administration: SOLUTION; INJECTION, ORAL, RECTAL
Strength: 38.8%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018956
Product Number: 001
Approval Date: Dec 26, 1985
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information

OMNIPAQUE 240 (IOHEXOL)
51.8%
Marketing Status: Prescription

Active Ingredient: IOHEXOL
Proprietary Name: OMNIPAQUE 240
Dosage Form; Route of Administration: SOLUTION; INJECTION, ORAL, RECTAL
Strength: 51.8%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018956
Product Number: 002
Approval Date: Dec 26, 1985
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: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018956
Product Number: 003
Approval Date: Dec 26, 1985
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information

OMNIPAQUE 12 (IOHEXOL)
2.6%
Marketing Status: Prescription

Active Ingredient: IOHEXOL
Proprietary Name: OMNIPAQUE 12
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 2.6%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018956
Product Number: 009
Approval Date: Apr 17, 2018
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information

OMNIPAQUE 9 (IOHEXOL)
1.9%
Marketing Status: Prescription

Active Ingredient: IOHEXOL
Proprietary Name: OMNIPAQUE 9
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 1.9%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018956
Product Number: 008
Approval Date: Apr 17, 2018
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information

OMNIPAQUE 210 (IOHEXOL)
45.3%
Marketing Status: Discontinued

Active Ingredient: IOHEXOL
Proprietary Name: OMNIPAQUE 210
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 45.3%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018956
Product Number: 006
Approval Date: Jun 30, 1989
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information

OMNIPAQUE 70 (IOHEXOL)
15.1%
Marketing Status: Discontinued

Active Ingredient: IOHEXOL
Proprietary Name: OMNIPAQUE 70
Dosage Form; Route of Administration: SOLUTION; URETHRAL
Strength: 15.1%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018956
Product Number: 007
Approval Date: Jun 1, 1994
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information