APPLICATION
ANDA090886
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-10
LATEST ACTION
2024-01-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RISEDRONATE SODIUMPrescription
RISEDRONATE SODIUM 75MG · TABLET · ORAL
RISEDRONATE SODIUMPrescription
RISEDRONATE SODIUM 30MG · TABLET · ORAL
RISEDRONATE SODIUMPrescription
RISEDRONATE SODIUM 150MG · TABLET · ORAL
RISEDRONATE SODIUMPrescription
RISEDRONATE SODIUM 35MG · TABLET · ORAL
RISEDRONATE SODIUMPrescription
RISEDRONATE SODIUM 5MG · TABLET · ORAL
Approval history
2024-01-08Labeling · Supplement 11 · standardAP
2023-04-28Labeling · Supplement 7 · standardAP
2015-11-30OriginalAP
2015-10-23Labeling · Supplement 2 · standardAP
2014-06-10OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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