Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018035

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DRAXIMAGE MDP-25 (TECHNETIUM TC-99M MEDRONATE)
N/A
Marketing Status: Prescription

Active Ingredient: TECHNETIUM TC-99M MEDRONATE
Proprietary Name: DRAXIMAGE MDP-25
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: N/A
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018035
Product Number: 002
Approval Date: Feb 27, 2004
Applicant Holder Full Name: JUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA
Marketing Status:  Prescription
Patent and Exclusivity Information

DRAXIMAGE MDP-10 (TECHNETIUM TC-99M MEDRONATE)
N/A
Marketing Status: Discontinued

Active Ingredient: TECHNETIUM TC-99M MEDRONATE
Proprietary Name: DRAXIMAGE MDP-10
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: N/A
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018035
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: JUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA
Marketing Status:  Discontinued
Patent and Exclusivity Information