APPLICATION
NDA050051
TYPE
NDA
ORIGINAL APPROVAL
1962-08-22
LATEST ACTION
1996-05-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
GRISACTINDiscontinued
GRISEOFULVIN, MICROCRYSTALLINE 250MG · CAPSULE · ORAL
GRISACTINDiscontinued
GRISEOFULVIN, MICROCRYSTALLINE 125MG · CAPSULE · ORAL
Approval history
1996-05-09Manufacturing (CMC) · Supplement 65AP
1993-01-28Manufacturing (CMC) · Supplement 5AP
1987-07-29Manufacturing (CMC) · Supplement 4AP
1984-01-12Manufacturing (CMC) · Supplement 2AP
1983-06-29Manufacturing (CMC) · Supplement 1AP
1981-05-26Manufacturing (CMC) · Supplement 64AP
1981-05-20Manufacturing (CMC) · Supplement 63AP
1981-02-19Manufacturing (CMC) · Supplement 62AP
1980-12-31Manufacturing (CMC) · Supplement 61AP
1980-08-27Manufacturing (CMC) · Supplement 60AP
1980-06-24Manufacturing (CMC) · Supplement 59AP
1980-01-21Manufacturing (CMC) · Supplement 58AP
1979-11-08Manufacturing (CMC) · Supplement 57AP
1979-11-08Manufacturing (CMC) · Supplement 56AP
1978-10-18Manufacturing (CMC) · Supplement 55AP
1977-06-21Manufacturing (CMC) · Supplement 54AP
1977-06-10Manufacturing (CMC) · Supplement 53AP
1976-10-29Manufacturing (CMC) · Supplement 52AP
1976-05-13Manufacturing (CMC) · Supplement 50AP
1976-04-01Manufacturing (CMC) · Supplement 49AP
1975-11-11Manufacturing (CMC) · Supplement 48AP
1975-09-30Manufacturing (CMC) · Supplement 47AP
1974-10-16Manufacturing (CMC) · Supplement 51AP
1974-06-05Manufacturing (CMC) · Supplement 46AP
1974-05-22Manufacturing (CMC) · Supplement 45AP
1974-02-22Manufacturing (CMC) · Supplement 44AP
1973-02-12Manufacturing (CMC) · Supplement 43AP
1973-02-02Manufacturing (CMC) · Supplement 42AP
1972-06-20Manufacturing (CMC) · Supplement 37AP
1972-06-16Labeling · Supplement 41AP
1972-05-03Labeling · Supplement 40AP
1972-03-27Manufacturing (CMC) · Supplement 39AP
1972-02-03Manufacturing (CMC) · Supplement 38AP
1971-11-12Labeling · Supplement 35AP
1971-09-13Labeling · Supplement 34AP
1971-06-28Labeling · Supplement 33AP
1971-06-03Manufacturing (CMC) · Supplement 32AP
1969-07-29Manufacturing (CMC) · Supplement 31AP
1969-07-15Manufacturing (CMC) · Supplement 29AP
1969-07-15Manufacturing (CMC) · Supplement 30AP
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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