APPLICATION
ANDA070313
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-16
LATEST ACTION
2025-06-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DIAZEPAMPrescription
DIAZEPAM 10MG/2ML (5MG/ML) · INJECTABLE · INJECTION
Approval history
2025-06-13Labeling · Supplement 31 · standardAP
2025-06-13Labeling · Supplement 30 · standardAP
2023-01-17Labeling · Supplement 27 · standardAP
2021-06-14Labeling · Supplement 24 · standardAP
2021-02-05Labeling · Supplement 22 · standardAP
2016-12-16Labeling · Supplement 21 · standardAP
2016-12-08Labeling · Supplement 20 · standardAP
2000-04-21Manufacturing (CMC) · Supplement 19AP
1998-12-14Manufacturing (CMC) · Supplement 18AP
1998-11-16Manufacturing (CMC) · Supplement 17AP
1998-03-17Manufacturing (CMC) · Supplement 16AP
1997-07-08Manufacturing (CMC) · Supplement 15AP
1997-07-08Manufacturing (CMC) · Supplement 14AP
1993-06-22Labeling · Supplement 12AP
1990-05-30Labeling · Supplement 11AP
1988-09-07Labeling · Supplement 10AP
1988-06-28Manufacturing (CMC) · Supplement 7AP
1988-05-18Labeling · Supplement 9AP
1988-02-26Labeling · Supplement 8AP
1987-10-07Manufacturing (CMC) · Supplement 3AP
1987-10-07Manufacturing (CMC) · Supplement 1AP
1986-11-03Manufacturing (CMC) · Supplement 4AP
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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