Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 010040

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CYSTOGRAFIN (DIATRIZOATE MEGLUMINE)
30%
Marketing Status: Prescription

Active Ingredient: DIATRIZOATE MEGLUMINE
Proprietary Name: CYSTOGRAFIN
Dosage Form; Route of Administration: SOLUTION; URETHRAL
Strength: 30%
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N010040
Product Number: 018
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CYSTOGRAFIN DILUTE (DIATRIZOATE MEGLUMINE)
18%
Marketing Status: Prescription

Active Ingredient: DIATRIZOATE MEGLUMINE
Proprietary Name: CYSTOGRAFIN DILUTE
Dosage Form; Route of Administration: SOLUTION; URETHRAL
Strength: 18%
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N010040
Product Number: 022
Approval Date: Nov 9, 1982
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DIATRIZOATE MEGLUMINE (DIATRIZOATE MEGLUMINE)
76%
Marketing Status: Discontinued

Active Ingredient: DIATRIZOATE MEGLUMINE
Proprietary Name: DIATRIZOATE MEGLUMINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 76%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N010040
Product Number: 017
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RENO-60 (DIATRIZOATE MEGLUMINE)
60%
Marketing Status: Discontinued

Active Ingredient: DIATRIZOATE MEGLUMINE
Proprietary Name: RENO-60
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 60%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N010040
Product Number: 016
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RENO-DIP (DIATRIZOATE MEGLUMINE)
30%
Marketing Status: Discontinued

Active Ingredient: DIATRIZOATE MEGLUMINE
Proprietary Name: RENO-DIP
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 30%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N010040
Product Number: 012
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RENO-30 (DIATRIZOATE MEGLUMINE)
30%
Marketing Status: Discontinued

Active Ingredient: DIATRIZOATE MEGLUMINE
Proprietary Name: RENO-30
Dosage Form; Route of Administration: SOLUTION; URETERAL
Strength: 30%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N010040
Product Number: 021
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RENOGRAFIN-60 (DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM)
52%;8%
Marketing Status: Discontinued

Active Ingredient: DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Proprietary Name: RENOGRAFIN-60
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 52%;8%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N010040
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RENOGRAFIN-76 (DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM)
66%;10%
Marketing Status: Discontinued

Active Ingredient: DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Proprietary Name: RENOGRAFIN-76
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 66%;10%
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N010040
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RENOVIST (DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM)
34.3%;35%
Marketing Status: Discontinued

Active Ingredient: DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Proprietary Name: RENOVIST
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 34.3%;35%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N010040
Product Number: 020
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RENOVIST II (DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM)
28.5%;29.1%
Marketing Status: Discontinued

Active Ingredient: DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Proprietary Name: RENOVIST II
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 28.5%;29.1%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N010040
Product Number: 019
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information