APPLICATION
ANDA203533
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-09
LATEST ACTION
2024-05-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RISEDRONATE SODIUMPrescription
RISEDRONATE SODIUM 35MG · TABLET · ORAL
RISEDRONATE SODIUMPrescription
RISEDRONATE SODIUM 5MG · TABLET · ORAL
RISEDRONATE SODIUMPrescription
RISEDRONATE SODIUM 30MG · TABLET · ORAL
Approval history
2024-05-23Labeling · Supplement 24 · standardAP
2024-05-23Labeling · Supplement 2 · standardAP
2024-05-23Labeling · Supplement 13 · standardAP
2023-06-07Labeling · Supplement 20 · standardAP
2016-11-29UNKNOWN · OriginalAP
2015-12-09UNKNOWN · OriginalAP
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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