APPLICATION
ANDA072397
TYPE
ANDA
ORIGINAL APPROVAL
1993-01-29
LATEST ACTION
2016-12-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DIAZEPAMDiscontinued
DIAZEPAM 5MG/ML · INJECTABLE · INJECTION
Approval history
2016-12-16Labeling · Supplement 6 · standardAP
1996-08-16Manufacturing (CMC) · Supplement 4AP
1996-08-16Manufacturing (CMC) · Supplement 2AP
1996-08-16Manufacturing (CMC) · Supplement 5AP
1996-08-16Labeling · Supplement 3AP
1994-03-23Manufacturing (CMC) · Supplement 1AP
1993-01-29OriginalAP
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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