APPLICATION
ANDA071415
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-03
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
DIAZEPAM INTENSOLPrescription
DIAZEPAM 5MG/ML · CONCENTRATE · ORAL
Approval history
2023-01-17Labeling · Supplement 18 · standardAP
2021-02-05Labeling · Supplement 17 · standardAP
2020-07-27Manufacturing (CMC) · Supplement 16 · unknownAP
2016-05-02Labeling · Supplement 14 · standardAP
2001-04-20Manufacturing (CMC) · Supplement 9AP
2000-09-21Manufacturing (CMC) · Supplement 8AP
1998-12-09Labeling · Supplement 7AP
1996-08-28Manufacturing (CMC) · Supplement 6AP
1994-12-09Labeling · Supplement 5AP
1990-06-11Labeling · Supplement 4AP
1990-01-26Labeling · Supplement 1AP
1989-04-20Bioequivalence · 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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