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FDA ANDA · ANDA062438

GRISACTIN ULTRA

Sponsor: WYETH AYERST

APPLICATION
ANDA062438
TYPE
ANDA
ORIGINAL APPROVAL
1983-11-17
LATEST ACTION
1994-01-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GRISACTIN ULTRADiscontinued
GRISEOFULVIN, ULTRAMICROCRYSTALLINE 165MG · TABLET · ORAL
GRISACTIN ULTRADiscontinued
GRISEOFULVIN, ULTRAMICROCRYSTALLINE 330MG · TABLET · ORAL

Approval history

1994-01-31Manufacturing (CMC) · Supplement 11AP
1991-09-03Manufacturing (CMC) · Supplement 8AP
1991-06-20Bioequivalence · Supplement 10AP
1990-03-27Manufacturing (CMC) · Supplement 9AP
1988-02-08Manufacturing (CMC) · Supplement 7AP
1987-07-01Manufacturing (CMC) · Supplement 6AP
1983-11-17OriginalAP
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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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