APPLICATION
ANDA070706
TYPE
ANDA
ORIGINAL APPROVAL
1986-03-19
LATEST ACTION
2003-11-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DIAZEPAMDiscontinued
DIAZEPAM 5MG · TABLET · ORAL
Approval history
2003-11-20Labeling · Supplement 14AP
2002-10-11Manufacturing (CMC) · Supplement 12AP
2001-11-02Manufacturing (CMC) · Supplement 11AP
2000-10-25Manufacturing (CMC) · Supplement 9AP
2000-10-25Manufacturing (CMC) · Supplement 10AP
1999-11-04Manufacturing (CMC) · Supplement 8AP
1999-07-20Manufacturing (CMC) · Supplement 7AP
1996-01-18Manufacturing (CMC) · Supplement 6AP
1993-03-31Labeling · Supplement 5AP
1988-10-06Labeling · Supplement 4AP
1988-06-07Labeling · Supplement 3AP
1988-01-21Manufacturing (CMC) · Supplement 2AP
1988-01-21Manufacturing (CMC) · Supplement 1AP
1986-03-19OriginalAP
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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