APPLICATION
ANDA070312
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-16
LATEST ACTION
2023-01-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DIAZEPAMDiscontinued
DIAZEPAM 5MG/ML · INJECTABLE · INJECTION
Approval history
2023-01-17Labeling · Supplement 19 · standardAP
2021-06-03Labeling · Supplement 17 · standardAP
2021-02-05Labeling · Supplement 16 · standardAP
2016-12-16Labeling · Supplement 15 · standardAP
2016-12-08Labeling · Supplement 14 · standardAP
2000-04-21Manufacturing (CMC) · Supplement 12AP
1998-11-16Manufacturing (CMC) · Supplement 11AP
1998-03-17Manufacturing (CMC) · Supplement 10AP
1997-07-08Manufacturing (CMC) · Supplement 9AP
1993-06-22Labeling · Supplement 7AP
1991-01-23Labeling · Supplement 6AP
1988-09-07Labeling · Supplement 5AP
1988-02-26Labeling · Supplement 4AP
1986-11-03Manufacturing (CMC) · Supplement 2AP
1986-08-08Manufacturing (CMC) · Supplement 1AP
1985-12-16OriginalAP
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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