APPLICATION
ANDA070228
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-26
LATEST ACTION
1997-12-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DIAZEPAMDiscontinued
DIAZEPAM 5MG · TABLET · ORAL
DIAZEPAMDiscontinued
DIAZEPAM 10MG · TABLET · ORAL
DIAZEPAMDiscontinued
DIAZEPAM 2MG · TABLET · ORAL
Approval history
1997-12-05Manufacturing (CMC) · Supplement 14AP
1997-11-19Manufacturing (CMC) · Supplement 13AP
1997-11-19Labeling · Supplement 11AP
1997-11-19Manufacturing (CMC) · Supplement 12AP
1994-08-25Labeling · Supplement 9AP
1989-05-19Labeling · Supplement 8AP
1988-06-14Labeling · Supplement 7AP
1987-11-17Manufacturing (CMC) · Supplement 6AP
1987-08-26Manufacturing (CMC) · Supplement 4AP
1987-08-26Manufacturing (CMC) · Supplement 5AP
1987-03-24Manufacturing (CMC) · Supplement 3AP
1987-03-24Manufacturing (CMC) · Supplement 1AP
1985-09-26OriginalAP
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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