APPLICATION
ANDA084399
TYPE
ANDA
ORIGINAL APPROVAL
1981-05-28
LATEST ACTION
1993-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PHENDIMETRAZINE TARTRATEDiscontinued
PHENDIMETRAZINE TARTRATE 35MG · TABLET · ORAL
Approval history
1993-10-18Manufacturing (CMC) · Supplement 19AP
1992-03-27Labeling · Supplement 18AP
1991-09-30Labeling · Supplement 17AP
1990-09-27Labeling · Supplement 16AP
1988-06-10Manufacturing (CMC) · Supplement 15AP
1987-04-16Manufacturing (CMC) · Supplement 13AP
1987-04-16Manufacturing (CMC) · Supplement 12AP
1986-02-11Manufacturing (CMC) · Supplement 8AP
1985-03-27Manufacturing (CMC) · Supplement 7AP
1985-03-27Manufacturing (CMC) · Supplement 6AP
1982-12-16Manufacturing (CMC) · Supplement 1AP
1982-12-16Manufacturing (CMC) · Supplement 2AP
1981-05-28OriginalAP
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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