APPLICATION
ANDA085034
TYPE
ANDA
ORIGINAL APPROVAL
1978-04-19
LATEST ACTION
1991-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALPHAZINEDiscontinued
PHENDIMETRAZINE TARTRATE 35MG · TABLET · ORAL
Approval history
1991-10-10Labeling · Supplement 13AP
1991-02-20Labeling · Supplement 12AP
1989-10-24Labeling · Supplement 11AP
1985-06-13Manufacturing (CMC) · Supplement 10AP
1982-09-24Manufacturing (CMC) · Supplement 7AP
1982-08-30Manufacturing (CMC) · Supplement 6AP
1978-04-19OriginalAP
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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