Product Details for NDA 021425
ULTRAVIST (PHARMACY BULK) (IOPROMIDE)
62.3%
Marketing Status: Prescription
76.9%
Marketing Status: Prescription
49.9%
Marketing Status: Discontinued
62.3%
Marketing Status: Prescription
Active Ingredient: IOPROMIDE
Proprietary Name: ULTRAVIST (PHARMACY BULK)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 62.3%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N021425
Product Number: 001
Approval Date: Sep 20, 2002
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
ULTRAVIST (PHARMACY BULK) (IOPROMIDE)
Proprietary Name: ULTRAVIST (PHARMACY BULK)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 62.3%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N021425
Product Number: 001
Approval Date: Sep 20, 2002
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
76.9%
Marketing Status: Prescription
Active Ingredient: IOPROMIDE
Proprietary Name: ULTRAVIST (PHARMACY BULK)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 76.9%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N021425
Product Number: 002
Approval Date: Sep 20, 2002
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
ULTRAVIST (PHARMACY BULK) (IOPROMIDE)
Proprietary Name: ULTRAVIST (PHARMACY BULK)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 76.9%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N021425
Product Number: 002
Approval Date: Sep 20, 2002
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
49.9%
Marketing Status: Discontinued
Active Ingredient: IOPROMIDE
Proprietary Name: ULTRAVIST (PHARMACY BULK)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 49.9%
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021425
Product Number: 003
Approval Date: Mar 12, 2004
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ULTRAVIST (PHARMACY BULK)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 49.9%
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021425
Product Number: 003
Approval Date: Mar 12, 2004
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information