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FDA ANDA · ANDA079049

ALENDRONATE SODIUM

Sponsor: CHARTWELL RX

APPLICATION
ANDA079049
TYPE
ANDA
ORIGINAL APPROVAL
2008-08-04
LATEST ACTION
2015-11-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2015-11-19Labeling · Supplement 5 · standardAP
2015-11-19Labeling · Supplement 4 · standardAP
2011-11-29REMS · Supplement 3AP
2011-05-17Labeling · Supplement 2AP
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.

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