APPLICATION
ANDA070302
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-20
LATEST ACTION
2025-08-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DIAZEPAMDiscontinued
DIAZEPAM 2MG · TABLET · ORAL
Approval history
2025-08-08Labeling · Supplement 14 · standardAP
2001-05-09Manufacturing (CMC) · Supplement 10AP
1995-02-09Manufacturing (CMC) · Supplement 9AP
1993-04-21Labeling · Supplement 8AP
1988-07-18Labeling · Supplement 7AP
1988-02-23Manufacturing (CMC) · Supplement 4AP
1988-02-23Manufacturing (CMC) · Supplement 5AP
1988-02-23Manufacturing (CMC) · Supplement 3AP
1987-08-19Manufacturing (CMC) · Supplement 2AP
1987-04-16Manufacturing (CMC) · Supplement 1AP
1985-12-20OriginalAP
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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