Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021223

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ZOMETA (ZOLEDRONIC ACID)
EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ZOLEDRONIC ACID
Proprietary Name: ZOMETA
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021223
Product Number: 001
Approval Date: Aug 20, 2001
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

ZOMETA (ZOLEDRONIC ACID)
EQ 4MG BASE/5ML
Marketing Status: Discontinued

Active Ingredient: ZOLEDRONIC ACID
Proprietary Name: ZOMETA
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 4MG BASE/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021223
Product Number: 002
Approval Date: Mar 7, 2003
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

ZOMETA (ZOLEDRONIC ACID)
EQ 4MG BASE/100ML
Marketing Status: Discontinued

Active Ingredient: ZOLEDRONIC ACID
Proprietary Name: ZOMETA
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 4MG BASE/100ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021223
Product Number: 003
Approval Date: Jun 17, 2011
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information