APPLICATION
ANDA085633
TYPE
ANDA
ORIGINAL APPROVAL
1978-07-13
LATEST ACTION
1995-07-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHENDIMETRAZINE TARTRATEDiscontinued
PHENDIMETRAZINE TARTRATE 35MG · CAPSULE · ORAL
Approval history
1995-07-19Manufacturing (CMC) · Supplement 19AP
1995-07-19Manufacturing (CMC) · Supplement 17AP
1988-12-06Labeling · Supplement 16AP
1985-06-14Manufacturing (CMC) · Supplement 14AP
1982-08-30Manufacturing (CMC) · Supplement 11AP
1982-08-11Manufacturing (CMC) · Supplement 1AP
1982-08-11Manufacturing (CMC) · Supplement 8AP
1982-05-24Manufacturing (CMC) · Supplement 7AP
1982-05-24Manufacturing (CMC) · Supplement 5AP
1978-07-13OriginalAP
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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