Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020103

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ZOFRAN (ONDANSETRON HYDROCHLORIDE)
EQ 4MG BASE
Marketing Status: Prescription
Active Ingredient: ONDANSETRON HYDROCHLORIDE
Proprietary Name: ZOFRAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020103
Product Number: 001
Approval Date: Dec 31, 1992
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
ZOFRAN (ONDANSETRON HYDROCHLORIDE)
EQ 8MG BASE
Marketing Status: Prescription
Active Ingredient: ONDANSETRON HYDROCHLORIDE
Proprietary Name: ZOFRAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 8MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020103
Product Number: 002
Approval Date: Dec 31, 1992
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
ZOFRAN (ONDANSETRON HYDROCHLORIDE)
EQ 24MG BASE
Marketing Status: Prescription
Active Ingredient: ONDANSETRON HYDROCHLORIDE
Proprietary Name: ZOFRAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 24MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020103
Product Number: 003
Approval Date: Aug 27, 1999
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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