APPLICATION
ANDA085695
TYPE
ANDA
ORIGINAL APPROVAL
1978-06-05
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 16AP
1995-07-19Manufacturing (CMC) · Supplement 17AP
1989-01-31Labeling · Supplement 14AP
1985-06-13Manufacturing (CMC) · Supplement 12AP
1982-08-30Manufacturing (CMC) · Supplement 9AP
1982-08-10Manufacturing (CMC) · Supplement 8AP
1982-06-11Manufacturing (CMC) · Supplement 7AP
1978-06-05OriginalAP
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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