APPLICATION
ANDA085402
TYPE
ANDA
ORIGINAL APPROVAL
1978-05-19
LATEST ACTION
1995-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PHENDIMETRAZINE TARTRATEDiscontinued
PHENDIMETRAZINE TARTRATE 35MG · TABLET · ORAL
Approval history
1995-10-30Manufacturing (CMC) · Supplement 24AP
1995-07-19Manufacturing (CMC) · Supplement 19AP
1995-07-19Manufacturing (CMC) · Supplement 17AP
1993-04-27Labeling · Supplement 23AP
1992-11-05Labeling · Supplement 22AP
1991-10-10Labeling · Supplement 21AP
1991-02-20Labeling · Supplement 20AP
1989-12-04Labeling · Supplement 16AP
1985-06-13Manufacturing (CMC) · Supplement 14AP
1982-09-24Manufacturing (CMC) · Supplement 11AP
1982-08-10Manufacturing (CMC) · Supplement 10AP
1982-08-10Manufacturing (CMC) · Supplement 3AP
1982-05-13Manufacturing (CMC) · Supplement 5AP
1978-05-19OriginalAP
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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