APPLICATION
ANDA071583
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-13
LATEST ACTION
2023-04-25
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DIAZEPAMPrescription
DIAZEPAM 50MG/10ML (5MG/ML) · INJECTABLE · INJECTION
Approval history
2023-04-25Labeling · Supplement 26 · standardAP
2021-02-05Labeling · Supplement 25 · standardAP
2019-02-21Labeling · Supplement 23 · standardAP
2016-12-16Labeling · Supplement 21 · standardAP
2015-04-06Labeling · Supplement 20 · standardAP
1999-04-30Manufacturing (CMC) · Supplement 6AP
1994-01-06Manufacturing (CMC) · Supplement 5AP
1993-06-23Labeling · Supplement 4AP
1990-04-03Labeling · Supplement 3AP
1990-03-09Labeling · Supplement 2AP
1989-03-16Labeling · Supplement 1AP
1987-10-13OriginalAP
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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