APPLICATION
ANDA085318
TYPE
ANDA
ORIGINAL APPROVAL
1977-01-18
LATEST ACTION
2000-10-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CAM-METRAZINEDiscontinued
PHENDIMETRAZINE TARTRATE 35MG · TABLET · ORAL
Approval history
2000-10-06Manufacturing (CMC) · Supplement 72AP
1992-03-24Labeling · Supplement 67AP
1989-12-13Labeling · Supplement 66AP
1988-06-27Manufacturing (CMC) · Supplement 63AP
1988-04-25Manufacturing (CMC) · Supplement 56AP
1988-04-25Manufacturing (CMC) · Supplement 62AP
1984-05-18Manufacturing (CMC) · Supplement 59AP
1984-04-12Manufacturing (CMC) · Supplement 58AP
1984-04-12Manufacturing (CMC) · Supplement 57AP
1984-04-12Manufacturing (CMC) · Supplement 51AP
1983-06-07Manufacturing (CMC) · Supplement 52AP
1983-06-07Manufacturing (CMC) · Supplement 55AP
1977-01-18OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.