APPLICATION
ANDA070296
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-12
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 20 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 18AP
1999-01-25Manufacturing (CMC) · Supplement 17AP
1994-03-08Labeling · Supplement 15AP
1991-02-21Manufacturing (CMC) · Supplement 12AP
1990-07-09Labeling · Supplement 14AP
1989-10-18Labeling · Supplement 11AP
1988-06-02Labeling · Supplement 7AP
1988-06-02Manufacturing (CMC) · Supplement 8AP
1987-10-28Manufacturing (CMC) · Supplement 3AP
1987-10-28Manufacturing (CMC) · Supplement 2AP
1987-03-25Manufacturing (CMC) · Supplement 5AP
1986-06-12Manufacturing (CMC) · Supplement 1AP
1986-02-12OriginalAP
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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