APPLICATION
ANDA072079
TYPE
ANDA
ORIGINAL APPROVAL
1988-12-20
LATEST ACTION
2023-04-25
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DIAZEPAMPrescription
DIAZEPAM 10MG/2ML (5MG/ML) · INJECTABLE · INJECTION
Approval history
2023-04-25Labeling · Supplement 53 · standardAP
2021-02-05Labeling · Supplement 44 · standardAP
2019-02-21Labeling · Supplement 32 · standardAP
2016-12-16Labeling · Supplement 24 · standardAP
2015-04-06Labeling · Supplement 22 · standardAP
2014-04-23Manufacturing (CMC) · Supplement 18AP
2001-02-14Manufacturing (CMC) · Supplement 9AP
1995-12-22Manufacturing (CMC) · Supplement 8AP
1995-01-27Manufacturing (CMC) · Supplement 6AP
1993-09-29Labeling · Supplement 7AP
1993-01-25Manufacturing (CMC) · Supplement 5AP
1993-01-25Labeling · Supplement 4AP
1992-03-10Manufacturing (CMC) · Supplement 2AP
1989-05-24Manufacturing (CMC) · Supplement 1AP
1988-12-20OriginalAP
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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