APPLICATION
ANDA203822
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-11
LATEST ACTION
2024-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
RISEDRONATE SODIUMDiscontinued
RISEDRONATE SODIUM 35MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-07-11Labeling · Supplement 1 · standardAP
2018-09-11UNKNOWN · 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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