← FDA DRUG APPROVALS

FDA ANDA · ANDA076584

ALENDRONATE SODIUM

Sponsor: RISING

APPLICATION
ANDA076584
TYPE
ANDA
ORIGINAL APPROVAL
2008-08-04
LATEST ACTION
2026-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 35MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 5MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 70MG BASE · TABLET · ORAL
ALENDRONATE SODIUMDiscontinued
ALENDRONATE SODIUM EQ 10MG BASE · TABLET · ORAL

Approval history

2026-06-08Labeling · Supplement 18 · standardAP
2023-01-31Labeling · Supplement 16 · standardAP
2016-04-08Labeling · Supplement 15 · standardAP
2015-07-16Labeling · Supplement 14 · standardAP
2015-07-16Labeling · Supplement 12 · standardAP
2013-07-18Manufacturing (CMC) · Supplement 9AP
2012-10-17Labeling · Supplement 11 · standardAP
2011-05-04Labeling · Supplement 5AP
2011-05-02Labeling · Supplement 7AP
2009-11-20Labeling · Supplement 3AP
2008-08-04Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →