Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021455

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BONIVA (IBANDRONATE SODIUM)
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: IBANDRONATE SODIUM
Proprietary Name: BONIVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021455
Product Number: 002
Approval Date: Mar 24, 2005
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
BONIVA (IBANDRONATE SODIUM)
EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: IBANDRONATE SODIUM
Proprietary Name: BONIVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021455
Product Number: 001
Approval Date: May 16, 2003
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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