APPLICATION
NDA006008
TYPE
NDA
ORIGINAL APPROVAL
1946-10-23
LATEST ACTION
2001-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MESANTOIN · ReferenceDiscontinued
MEPHENYTOIN 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-04-02Manufacturing (CMC) · Supplement 49AP
1999-04-23Manufacturing (CMC) · Supplement 48AP
1997-07-15Manufacturing (CMC) · Supplement 46AP
1996-07-23Manufacturing (CMC) · Supplement 39AP
1996-02-21Manufacturing (CMC) · Supplement 45AP
1995-08-14Manufacturing (CMC) · Supplement 43AP
1995-02-15Manufacturing (CMC) · Supplement 44AP
1994-12-14Labeling · Supplement 42AP
1994-12-14Labeling · Supplement 41AP
1994-11-23Manufacturing (CMC) · Supplement 40AP
1994-07-01Manufacturing (CMC) · Supplement 38AP
1987-11-10Labeling · Supplement 35AP
1986-08-27Manufacturing (CMC) · Supplement 34AP
1986-08-27Manufacturing (CMC) · Supplement 32AP
1984-12-05Manufacturing (CMC) · Supplement 33AP
1983-08-08Manufacturing (CMC) · Supplement 31AP
1981-07-20Manufacturing (CMC) · Supplement 30AP
1981-03-06Manufacturing (CMC) · Supplement 27AP
1980-07-24Labeling · Supplement 26AP
1979-06-14Manufacturing (CMC) · Supplement 25AP
1978-09-28Manufacturing (CMC) · Supplement 24AP
1978-02-13Manufacturing (CMC) · Supplement 23AP
1977-02-18Manufacturing (CMC) · Supplement 22AP
1976-07-23Manufacturing (CMC) · Supplement 20AP
1976-07-20Manufacturing (CMC) · Supplement 21AP
1976-05-04Manufacturing (CMC) · Supplement 18AP
1976-05-04Manufacturing (CMC) · Supplement 19AP
1975-11-10Labeling · Supplement 15AP
1975-07-01Manufacturing (CMC) · Supplement 17AP
1974-09-20Manufacturing (CMC) · Supplement 14AP
1974-08-29Manufacturing (CMC) · Supplement 11AP
1946-10-23OriginalAP
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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