APPLICATION
ANDA070311
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-16
LATEST ACTION
2026-06-01
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
DIAZEPAMDiscontinued
DIAZEPAM 5MG/ML (5MG/ML) · INJECTABLE · INJECTION
DIAZEPAMDiscontinued
DIAZEPAM 10MG/2ML (5MG/ML) · INJECTABLE · INJECTION
DIAZEPAMPrescription
DIAZEPAM 50MG/10ML (5MG/ML) · INJECTABLE · INJECTION
Approval history
2026-06-01Manufacturing (CMC) · Supplement 28 · unknownAP
2024-12-16Labeling · Supplement 25 · standardAP
2023-01-17Labeling · Supplement 24 · standardAP
2021-05-17Labeling · Supplement 21 · standardAP
2021-02-08Labeling · Supplement 20 · standardAP
2021-02-05Labeling · Supplement 19 · standardAP
2021-02-05Labeling · Supplement 18 · standardAP
2000-04-21Manufacturing (CMC) · Supplement 15AP
1998-11-16Manufacturing (CMC) · Supplement 14AP
1998-03-17Manufacturing (CMC) · Supplement 13AP
1997-07-08Manufacturing (CMC) · Supplement 12AP
1993-11-18Manufacturing (CMC) · Supplement 11AP
1993-06-22Labeling · Supplement 9AP
1993-02-01Labeling · Supplement 8AP
1988-09-07Labeling · Supplement 6AP
1988-02-26Labeling · Supplement 5AP
1986-11-03Manufacturing (CMC) · Supplement 2AP
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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