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Summary for Generic Name: ibandronate sodium
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Tentative approvals for IBANDRONATE SODIUM
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Clinical Trials for: ibandronate sodiumBioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition Status: Completed Condition: Healthy BONVIVA(Ibandronate) PMS(Post-marketing Surveillance ) Status: Completed Condition: Osteoporosis BONVIVA(Ibandronate) Injection PMS(Post-marketing Surveillance) Status: Completed Condition: Osteoporosis BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy. Status: Completed Condition: Post-Menopausal Osteoporosis A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva Status: Completed Condition: Post-Menopausal Osteoporosis BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis Status: Completed Condition: Post-Menopausal Osteoporosis Courtesy of ClinicalTrials.org See more clinical trials for this drug | |||||||||||||||||||||||||||||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Patented / Exclusive Use | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Roche | BONIVA | ibandronate sodium | INJECTABLE; INTRAVENOUS | 021858 | Jan 6, 2006 | RX | Yes | <disabled> | NEW CHEMICAL ENTITY | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Roche | BONIVA | ibandronate sodium | INJECTABLE; INTRAVENOUS | 021858 | Jan 6, 2006 | RX | Yes | <disabled> | NEW DOSAGE FORM | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Roche | BONIVA | ibandronate sodium | INJECTABLE; INTRAVENOUS | 021858 | Jan 6, 2006 | RX | Yes | 4,927,814 | <disabled> | TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Roche | BONIVA | ibandronate sodium | INJECTABLE; INTRAVENOUS | 021858 | Jan 6, 2006 | RX | Yes | 5,662,918 | <disabled> | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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