APPLICATION
ANDA088021
TYPE
ANDA
ORIGINAL APPROVAL
1982-09-21
LATEST ACTION
2002-04-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BONTRILDiscontinued
PHENDIMETRAZINE TARTRATE 105MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2002-04-19Manufacturing (CMC) · Supplement 20AP
2001-05-03Manufacturing (CMC) · Supplement 19AP
2001-04-20Manufacturing (CMC) · Supplement 18AP
1996-12-11Manufacturing (CMC) · Supplement 16AP
1996-06-19Manufacturing (CMC) · Supplement 17AP
1994-09-29Manufacturing (CMC) · Supplement 15AP
1994-01-14Manufacturing (CMC) · Supplement 14AP
1994-01-14Manufacturing (CMC) · Supplement 13AP
1991-04-25Manufacturing (CMC) · Supplement 12AP
1991-02-01Labeling · Supplement 11AP
1989-11-15Labeling · Supplement 10AP
1984-11-27Manufacturing (CMC) · Supplement 7AP
1984-06-01Manufacturing (CMC) · Supplement 6AP
1984-01-10Manufacturing (CMC) · Supplement 3AP
1983-12-01Manufacturing (CMC) · Supplement 2AP
1982-09-21OriginalAP
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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