APPLICATION
NDA018685
TYPE
NDA
ORIGINAL APPROVAL
1983-12-09
LATEST ACTION
2002-09-13
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
GAVISCON · ReferenceDiscontinued
ALUMINUM HYDROXIDE 160MG, MAGNESIUM TRISILICATE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
GAVISCON · ReferenceDiscontinued
ALUMINUM HYDROXIDE 80MG, MAGNESIUM TRISILICATE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
Approval history
2002-09-13Manufacturing (CMC) · Supplement 15 · standardAP
2000-11-08Manufacturing (CMC) · Supplement 14 · standardAP
2000-09-22Manufacturing (CMC) · Supplement 13 · standardAP
2000-02-28Manufacturing (CMC) · Supplement 12 · standardAP
2000-02-07Manufacturing (CMC) · Supplement 11 · standardAP
1999-10-04Manufacturing (CMC) · Supplement 10 · standardAP
1999-04-29Manufacturing (CMC) · Supplement 6 · standardAP
1998-03-17Manufacturing (CMC) · Supplement 9 · standardAP
1997-12-01Manufacturing (CMC) · Supplement 7 · standardAP
1997-12-01Manufacturing (CMC) · Supplement 8 · standardAP
1995-01-25Labeling · Supplement 5 · standardAP
1991-10-01Manufacturing (CMC) · Supplement 4 · standardAP
1989-02-08Manufacturing (CMC) · Supplement 3 · standardAP
1985-02-25Manufacturing (CMC) · Supplement 2 · standardAP
1984-08-01Manufacturing (CMC) · Supplement 1 · standardAP
1983-12-09Type 4 - New Combination · Original · standardAP
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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