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FDA NDA · NDA022560

ATELVIA

risedronate sodium

Sponsor: APIL

APPLICATION
NDA022560
TYPE
NDA
ORIGINAL APPROVAL
2010-10-08
LATEST ACTION
2026-02-03
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

ATELVIA · ReferencePrescription
RISEDRONATE SODIUM 35MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2026-02-03Labeling · Supplement 13 · standard — Letter ↗AP
2020-08-18Labeling · Supplement 11 · standard — Label ↗AP
2015-04-08Labeling · Supplement 7 · standard — Letter ↗AP
2015-03-26Labeling · Supplement 6 · standard — Label ↗AP
2013-04-19Labeling · Supplement 5 · standard — Letter ↗AP
2012-08-13Labeling · Supplement 4 · standard — Label ↗AP
2011-08-22REMS · Supplement 3 — Letter ↗AP
2011-01-25Labeling · Supplement 1 · standard — Letter ↗AP
2011-01-25REMS · Supplement 2 — Label ↗AP
2010-10-08Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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