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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020623

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ANZEMET (DOLASETRON MESYLATE)
50MG
Marketing Status: Prescription
Active Ingredient: DOLASETRON MESYLATE
Proprietary Name: ANZEMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020623
Product Number: 001
Approval Date: Sep 11, 1997
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
ANZEMET (DOLASETRON MESYLATE)
100MG
Marketing Status: Discontinued
Active Ingredient: DOLASETRON MESYLATE
Proprietary Name: ANZEMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020623
Product Number: 002
Approval Date: Sep 11, 1997
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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