APPLICATION
ANDA090022
TYPE
ANDA
ORIGINAL APPROVAL
2008-09-10
LATEST ACTION
2016-04-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 35MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 5MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 70MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2016-04-08Labeling · Supplement 12 · standardAP
2015-09-29Labeling · Supplement 11 · standardAP
2015-09-29Labeling · Supplement 9 · standardAP
2013-05-07Labeling · Supplement 8 · standardAP
2012-11-28Labeling · Supplement 7 · standardAP
2011-12-01REMS · Supplement 6AP
2011-04-05Labeling · Supplement 5AP
2010-11-29Labeling · Supplement 4AP
2009-11-17Labeling · Supplement 2AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.