Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020923

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OPTIRAY 300 (IOVERSOL)
64%
Marketing Status: Prescription

Active Ingredient: IOVERSOL
Proprietary Name: OPTIRAY 300
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 64%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020923
Product Number: 004
Approval Date: May 13, 1999
Applicant Holder Full Name: LIEBEL-FLARSHEIM CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

OPTIRAY 320 (IOVERSOL)
68%
Marketing Status: Prescription

Active Ingredient: IOVERSOL
Proprietary Name: OPTIRAY 320
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 68%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020923
Product Number: 002
Approval Date: May 29, 1998
Applicant Holder Full Name: LIEBEL-FLARSHEIM CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

OPTIRAY 350 (IOVERSOL)
74%
Marketing Status: Prescription

Active Ingredient: IOVERSOL
Proprietary Name: OPTIRAY 350
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 74%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020923
Product Number: 003
Approval Date: May 28, 1998
Applicant Holder Full Name: LIEBEL-FLARSHEIM CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

OPTIRAY 240 (IOVERSOL)
51%
Marketing Status: Discontinued

Active Ingredient: IOVERSOL
Proprietary Name: OPTIRAY 240
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 51%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020923
Product Number: 001
Approval Date: May 28, 1998
Applicant Holder Full Name: LIEBEL-FLARSHEIM CO LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information