FDA.reportPublic FDA data

IBANDRONATE SODIUM - Food and Drug Administration

Set ID
fca0fe5b-9e2b-f6fc-e68d-b5f751d08578
Type
Indexing - Product Concept
Effective date
2018-01-03
Version
3
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameBionpharma Inc. | OrBion Pharmaceuticals Private Limited2026-08-26
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameAurobindo Pharma Limited2026-03-18
These highlights do not include all the information needed to use IBANDRONATE SODIUM INJECTION safely and effectively. See full prescribing information for IBANDRONATE SODIUM INJECTION. IBANDRONATE SODIUM injection, for intravenous use Initial U.S. Approval: 2003Product nameSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2026-03-03
IBANDRONATE SODIUM TABLETS. These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameGolden State Medical Supply, Inc. | Apotex Inc.2026-02-19
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameDr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO III2026-02-16
These highlights do not include all the information needed to use IBANDRONATE SODIUM INJECTION safely and effectively. See full prescribing information for IBANDRONATE SODIUM INJECTION. IBANDRONATE SODIUM injection, for intravenous use Initial U.S. Approval: 2003Product nameEugia US LLC | Apitoria Pharma Private Limited | EUGIA PHARMA SPECIALITIES LIMITED2026-01-27
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameAurobindo Pharma Limited2026-01-19
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameMacleods Pharmaceuticals Limited2026-01-19
These highlights do not include all the information needed to use IBANDRONATE SODIUM INJECTION safely and effectively. See full prescribing information for IBANDRONATE SODIUM INJECTION. IBANDRONATE SODIUM injection, for intravenous use Initial U.S. Approval: 2003Product nameEugia US LLC | Apitoria Pharma Private Limited | EUGIA PHARMA SPECIALITIES LIMITED2026-01-16
These highlights do not include all the information needed to use IBANDRONATE SODIUM INJECTION safely and effectively. See full prescribing information for IBANDRONATE SODIUM INJECTION . IBANDRONATE sodium injection, for intravenous use Initial U.S. Approval: 2003Product nameApotex Corp. | Apotex Inc.2026-01-15
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameApotex Corp | Apotex Inc2026-01-15
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameMacleods Pharmaceuticals Limited2025-11-17
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameAurobindo Pharma Limited2025-11-03
These highlights do not include all the information needed to use IBANDRONATE SODIUM INJECTION safely and effectively. See full prescribing information for IBANDRONATE SODIUM INJECTION. IBANDRONATE SODIUM injection, for intravenous use Initial U.S. Approval: 2003Product nameEugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED | Apitoria Pharma Private Limited2025-11-01
These highlights do not include all the information needed to use IBANDRONATE SODIUM INJECTION safely and effectively. See full prescribing information for IBANDRONATE SODIUM INJECTION . IBANDRONATE sodium injection, for intravenous use Initial U.S. Approval: 2003Product nameApotex Corp. | Apotex Inc.2025-10-31
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameDr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO III2025-10-27
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameApotex Corp | Apotex Inc2025-10-23
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameA-S Medication Solutions2025-09-22
These highlights do not include all the information needed to use IBANDRONATE SODIUM INJECTION safely and effectively. See full prescribing information for IBANDRONATE SODIUM INJECTION . IBANDRONATE sodium injection, for intravenous use Initial U.S. Approval: 2003Product nameApotex Corp. | Apotex Inc.2025-07-24
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameApotex Corp | Apotex Inc | Apotex Inc. | Legacy Pharmaceutical Packaging, LLC2025-04-02
These highlights do not include all the information needed to use IBANDRONATE SODIUM INJECTION safely and effectively. See full prescribing information for IBANDRONATE SODIUM INJECTION . IBANDRONATE SODIUM injection, for intravenous use Initial U.S. Approval: 2003Product nameMylan Institutional LLC | Mylan Laboratories Limited | Steriscience Specialties Private Limited2024-10-15
These highlights do not include all the information needed to use IBANDRONATE SODIUM INJECTION safely and effectively. See full prescribing information for IBANDRONATE SODIUM INJECTION. IBANDRONATE SODIUM Injection, for intravenous use Initial U.S. Approval: 2003Product nameAccord Healthcare Inc. | Intas Pharmaceuticals Limited.2024-01-09
These highlights do not include all the information needed to use IBANDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for IBANDRONATE SODIUM TABLETS. IBANDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 2003Product nameBionpharma Inc. | OrBion Pharmaceuticals Private Limited2023-05-23
These highlights do not include all the information needed to use BONIVA Tablets safely and effectively. See full prescribing information for BONIVA Tablets. BONIVA® (ibandronate sodium) Tablets Initial U.S. Approval: 2003Product namePhysicians Total Care, Inc.2010-12-02