APPLICATION
ANDA087378
TYPE
ANDA
ORIGINAL APPROVAL
1981-11-03
LATEST ACTION
1985-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PHENDIMETRAZINE TARTRATEDiscontinued
PHENDIMETRAZINE TARTRATE 105MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1985-10-07Manufacturing (CMC) · Supplement 12AP
1985-03-29Manufacturing (CMC) · Supplement 10AP
1983-07-12Manufacturing (CMC) · Supplement 4AP
1983-07-12Manufacturing (CMC) · Supplement 5AP
1983-07-12Manufacturing (CMC) · Supplement 3AP
1983-07-12Manufacturing (CMC) · Supplement 6AP
1981-11-03OriginalAP
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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