APPLICATION
ANDA070928
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-03
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
DIAZEPAMPrescription
DIAZEPAM 5MG/5ML · SOLUTION · ORAL
Approval history
2023-01-17Labeling · Supplement 19 · standardAP
2021-02-05Labeling · Supplement 18 · standardAP
2020-08-17Labeling · Supplement 17 · standardAP
2016-05-02Labeling · Supplement 16 · standardAP
1999-09-20Manufacturing (CMC) · Supplement 13AP
1998-12-09Labeling · Supplement 12AP
1998-09-10Manufacturing (CMC) · Supplement 11AP
1997-09-03Manufacturing (CMC) · Supplement 8AP
1996-08-28Manufacturing (CMC) · Supplement 7AP
1994-12-09Labeling · Supplement 6AP
1991-02-01Labeling · Supplement 4AP
1990-01-26Labeling · Supplement 3AP
1988-12-23Manufacturing (CMC) · Supplement 2AP
1987-04-03OriginalAP
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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