Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020624

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ANZEMET (DOLASETRON MESYLATE)
12.5MG/0.625ML (20MG/ML)
Marketing Status: Discontinued

Active Ingredient: DOLASETRON MESYLATE
Proprietary Name: ANZEMET
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 12.5MG/0.625ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020624
Product Number: 002
Approval Date: Sep 11, 1997
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ANZEMET (DOLASETRON MESYLATE)
100MG/5ML (20MG/ML)
Marketing Status: Discontinued

Active Ingredient: DOLASETRON MESYLATE
Proprietary Name: ANZEMET
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100MG/5ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020624
Product Number: 001
Approval Date: Sep 11, 1997
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ANZEMET (DOLASETRON MESYLATE)
500MG/25ML (20MG/ML)
Marketing Status: Discontinued

Active Ingredient: DOLASETRON MESYLATE
Proprietary Name: ANZEMET
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500MG/25ML (20MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020624
Product Number: 003
Approval Date: Dec 11, 2001
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information