APPLICATION
ANDA071322
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-10
LATEST ACTION
2015-03-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DIAZEPAMPrescription
DIAZEPAM 10MG · TABLET · ORAL
Approval history
2015-03-09Labeling · Supplement 33 · standardAP
2013-01-28Labeling · Supplement 31 · standardAP
2008-07-23Labeling · Supplement 26AP
2002-07-29Manufacturing (CMC) · Supplement 13AP
2002-03-27Manufacturing (CMC) · Supplement 11AP
2002-03-12Manufacturing (CMC) · Supplement 12AP
2000-01-28Manufacturing (CMC) · Supplement 10AP
1998-03-30Manufacturing (CMC) · Supplement 9AP
1996-10-30Manufacturing (CMC) · Supplement 7AP
1996-10-29Manufacturing (CMC) · Supplement 8AP
1993-10-22Labeling · Supplement 6AP
1991-07-25Manufacturing (CMC) · Supplement 5AP
1990-03-14Labeling · Supplement 3AP
1990-03-14Labeling · Supplement 4AP
1987-03-25Manufacturing (CMC) · Supplement 1AP
1987-03-25Manufacturing (CMC) · Supplement 2AP
1986-12-10OriginalAP
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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