← FDA DRUG APPROVALS

FDA NDA · NDA202344

BINOSTO

alendronate sodium

Sponsor: RADIUS

APPLICATION
NDA202344
TYPE
NDA
ORIGINAL APPROVAL
2012-03-12
LATEST ACTION
2026-02-03
ROUTE
ORAL
DOSAGE FORM
TABLET, EFFERVESCENT
MARKETING STATUS
Discontinued

Products

BINOSTO · ReferenceDiscontinued
ALENDRONATE SODIUM EQ 70MG BASE · TABLET, EFFERVESCENT · ORAL

Approval history

2026-02-03Labeling · Supplement 22 · standard — Letter ↗AP
2020-10-13Labeling · Supplement 15 · standard — Label ↗AP
2020-06-08Labeling · Supplement 13 · standard — Label ↗AP
2016-12-30Labeling · Supplement 11 · standard — Letter ↗AP
2016-03-22Labeling · Supplement 10 · standard — Letter ↗AP
2016-01-26Manufacturing (CMC) · Supplement 9 · standardAP
2015-04-08Labeling · Supplement 8 · standard — Label ↗AP
2015-02-26Labeling · Supplement 7 · standard — Label ↗AP
2013-12-23Manufacturing (CMC) · Supplement 6 · standardAP
2013-08-02Manufacturing (CMC) · Supplement 2 · standard — Label ↗AP
2013-04-19Labeling · Supplement 1 · standard — Label ↗AP
2013-04-17Manufacturing (CMC) · Supplement 4 · standardAP
2012-03-12Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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