← FDA DRUG APPROVALS

FDA ANDA · ANDA086013

STATOBEX

Sponsor: TEVA

APPLICATION
ANDA086013
TYPE
ANDA
ORIGINAL APPROVAL
1977-12-16
LATEST ACTION
1996-01-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

STATOBEXDiscontinued
PHENDIMETRAZINE TARTRATE 35MG · TABLET · ORAL

Approval history

1996-01-25Manufacturing (CMC) · Supplement 31AP
1996-01-25Manufacturing (CMC) · Supplement 32AP
1996-01-25Manufacturing (CMC) · Supplement 30AP
1995-03-02Manufacturing (CMC) · Supplement 29AP
1994-01-26Manufacturing (CMC) · Supplement 27AP
1994-01-26Manufacturing (CMC) · Supplement 25AP
1994-01-26Manufacturing (CMC) · Supplement 23AP
1994-01-26Manufacturing (CMC) · Supplement 21AP
1994-01-26Manufacturing (CMC) · Supplement 28AP
1994-01-26Manufacturing (CMC) · Supplement 26AP
1994-01-26Manufacturing (CMC) · Supplement 24AP
1994-01-26Manufacturing (CMC) · Supplement 22AP
1994-01-26Manufacturing (CMC) · Supplement 20AP
1993-09-22Manufacturing (CMC) · Supplement 19AP
1993-08-31Manufacturing (CMC) · Supplement 18AP
1993-05-25Manufacturing (CMC) · Supplement 17AP
1993-05-25Manufacturing (CMC) · Supplement 15AP
1993-05-25Manufacturing (CMC) · Supplement 13AP
1993-05-25Manufacturing (CMC) · Supplement 16AP
1993-05-25Manufacturing (CMC) · Supplement 12AP
1993-04-01Manufacturing (CMC) · Supplement 11AP
1993-04-01Manufacturing (CMC) · Supplement 14AP
1992-12-30Manufacturing (CMC) · Supplement 10AP
1991-08-22Labeling · Supplement 9AP
1988-12-19Labeling · Supplement 8AP
1986-05-15Manufacturing (CMC) · Supplement 2AP
1984-08-22Manufacturing (CMC) · Supplement 7AP
1984-08-22Manufacturing (CMC) · Supplement 6AP
1982-06-02Manufacturing (CMC) · Supplement 3AP
1982-06-02Manufacturing (CMC) · Supplement 1AP
1982-06-02Manufacturing (CMC) · Supplement 4AP
1977-12-16OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →