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FDA ANDA · ANDA071793

FOAMCOAT

Sponsor: GUARDIAN DRUG

APPLICATION
ANDA071793
TYPE
ANDA
ORIGINAL APPROVAL
1987-09-04
LATEST ACTION
2001-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

FOAMCOATDiscontinued
ALUMINUM HYDROXIDE 80MG, MAGNESIUM TRISILICATE 20MG · TABLET, CHEWABLE · ORAL

Approval history

2001-06-05Manufacturing (CMC) · Supplement 8AP
2001-06-05Manufacturing (CMC) · Supplement 6AP
2001-06-05Manufacturing (CMC) · Supplement 9AP
2001-06-05Manufacturing (CMC) · Supplement 7AP
2001-06-05Manufacturing (CMC) · Supplement 5AP
1992-11-25Manufacturing (CMC) · Supplement 3AP
1992-11-25Manufacturing (CMC) · Supplement 2AP
1987-09-04OriginalAP
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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