APPLICATION
ANDA203925
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-09
LATEST ACTION
2023-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
RISEDRONATE SODIUMDiscontinued
RISEDRONATE SODIUM 35MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2023-12-18Labeling · Supplement 1 · standardAP
2019-07-09UNKNOWN · 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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