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FDA ANDA · ANDA090124

ALENDRONATE SODIUM

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA090124
TYPE
ANDA
ORIGINAL APPROVAL
2008-08-04
LATEST ACTION
2026-04-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 35MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 70MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 10MG BASE · TABLET · ORAL

Approval history

2026-04-15Labeling · Supplement 23 · standardAP
2024-09-27Manufacturing (CMC) · Supplement 22 · unknownAP
2023-06-06Labeling · Supplement 16 · standardAP
2016-04-08Labeling · Supplement 14 · standardAP
2015-07-22Labeling · Supplement 12 · standardAP
2015-07-22Labeling · Supplement 10 · standardAP
2015-07-22Labeling · Supplement 9 · standardAP
2013-02-05Labeling · Supplement 7 · standardAP
2012-06-25Labeling · Supplement 6 · standardAP
2012-05-17Labeling · Supplement 5AP
2011-04-06Labeling · Supplement 4AP
2011-02-15Labeling · Supplement 3AP
2010-08-24Labeling · Supplement 2AP
2009-02-19Labeling · Supplement 1AP
2008-08-04Original — Other Important Information from FDA ↗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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