APPLICATION
ANDA200477
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-10
LATEST ACTION
2015-11-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RISEDRONATE SODIUMDiscontinued
RISEDRONATE SODIUM 150MG · TABLET · ORAL
RISEDRONATE SODIUMDiscontinued
RISEDRONATE SODIUM 35MG · TABLET · ORAL
RISEDRONATE SODIUMDiscontinued
RISEDRONATE SODIUM 5MG · TABLET · ORAL
RISEDRONATE SODIUMDiscontinued
RISEDRONATE SODIUM 75MG · TABLET · ORAL
RISEDRONATE SODIUMDiscontinued
RISEDRONATE SODIUM 30MG · TABLET · ORAL
Approval history
2015-11-30Not Applicable · OriginalAP
2015-11-17Labeling · Supplement 2 · standardAP
2014-06-10Not Applicable · 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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