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FDA ANDA · ANDA075800

ETIDRONATE DISODIUM

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA075800
TYPE
ANDA
ORIGINAL APPROVAL
2003-01-24
LATEST ACTION
2015-07-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ETIDRONATE DISODIUMDiscontinued
ETIDRONATE DISODIUM 200MG · TABLET · ORAL
ETIDRONATE DISODIUMDiscontinued
ETIDRONATE DISODIUM 400MG · TABLET · ORAL

Approval history

2015-07-15Labeling · Supplement 12 · standardAP
2015-07-15Labeling · Supplement 10 · standardAP
2010-02-19Labeling · Supplement 7AP
2006-08-29Labeling · Supplement 5AP
2005-04-05Labeling · Supplement 2AP
2003-01-24Original — 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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