APPLICATION
ANDA086365
TYPE
ANDA
ORIGINAL APPROVAL
1981-09-24
LATEST ACTION
1987-01-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PHENDIMETRAZINE TARTRATEDiscontinued
PHENDIMETRAZINE TARTRATE 35MG · TABLET · ORAL
Approval history
1987-01-16Manufacturing (CMC) · Supplement 11AP
1987-01-16Manufacturing (CMC) · Supplement 9AP
1987-01-16Manufacturing (CMC) · Supplement 10AP
1986-01-13Labeling · Supplement 12AP
1984-12-14Manufacturing (CMC) · Supplement 8AP
1984-01-17Manufacturing (CMC) · Supplement 5AP
1982-09-17Manufacturing (CMC) · Supplement 2AP
1982-07-27Manufacturing (CMC) · Supplement 1AP
1981-09-24OriginalAP
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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