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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076183

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ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
EQ 4MG BASE
Marketing Status: Prescription
Active Ingredient: ONDANSETRON HYDROCHLORIDE
Proprietary Name: ONDANSETRON HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076183
Product Number: 003
Approval Date: Dec 26, 2006
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
EQ 8MG BASE
Marketing Status: Prescription
Active Ingredient: ONDANSETRON HYDROCHLORIDE
Proprietary Name: ONDANSETRON HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 8MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076183
Product Number: 002
Approval Date: Dec 26, 2006
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
EQ 16MG BASE
Marketing Status: Discontinued
Active Ingredient: ONDANSETRON HYDROCHLORIDE
Proprietary Name: ONDANSETRON HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 16MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076183
Product Number: 004
Approval Date: Dec 26, 2006
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
EQ 24MG BASE
Marketing Status: Discontinued
Active Ingredient: ONDANSETRON HYDROCHLORIDE
Proprietary Name: ONDANSETRON HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 24MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076183
Product Number: 001
Approval Date: Dec 26, 2006
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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