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FDA ANDA · ANDA085321

CAM-METRAZINE

Sponsor: CHARTWELL RX

APPLICATION
ANDA085321
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 59AP
1991-08-20Labeling · Supplement 54AP
1989-12-13Labeling · Supplement 53AP
1988-10-24Manufacturing (CMC) · Supplement 51AP
1988-10-24Manufacturing (CMC) · Supplement 43AP
1988-06-27Manufacturing (CMC) · Supplement 50AP
1984-06-07Manufacturing (CMC) · Supplement 46AP
1984-04-18Manufacturing (CMC) · Supplement 45AP
1984-04-18Manufacturing (CMC) · Supplement 44AP
1983-06-09Manufacturing (CMC) · Supplement 42AP
1983-06-06Manufacturing (CMC) · Supplement 39AP
1983-06-06Manufacturing (CMC) · Supplement 38AP
1983-06-06Manufacturing (CMC) · Supplement 40AP
1977-01-18OriginalAP
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