APPLICATION
ANDA070325
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-04
LATEST ACTION
2024-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DIAZEPAMPrescription
DIAZEPAM 5MG · TABLET · ORAL
DIAZEPAMPrescription
DIAZEPAM 10MG · TABLET · ORAL
DIAZEPAMPrescription
DIAZEPAM 2MG · TABLET · ORAL
Approval history
2024-04-11Labeling · Supplement 27 · standardAP
2024-04-11Labeling · Supplement 25 · standardAP
2024-04-11Labeling · Supplement 24 · standardAP
2024-04-11Labeling · Supplement 30 · standardAP
2008-11-25Labeling · Supplement 19AP
2002-12-19Labeling · Supplement 12AP
1998-02-25Manufacturing (CMC) · Supplement 11AP
1998-02-05Manufacturing (CMC) · Supplement 10AP
1993-09-30Manufacturing (CMC) · Supplement 9AP
1993-05-14Labeling · Supplement 31AP
1993-05-14Labeling · Supplement 7AP
1989-12-29Labeling · Supplement 4AP
1989-06-19Manufacturing (CMC) · Supplement 5AP
1988-02-03Manufacturing (CMC) · Supplement 3AP
1986-12-08Manufacturing (CMC) · Supplement 2AP
1985-09-04OriginalAP
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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