APPLICATION
ANDA086383
TYPE
ANDA
ORIGINAL APPROVAL
1978-09-08
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
CHLORDIAZEPOXIDE HYDROCHLORIDEDiscontinued
CHLORDIAZEPOXIDE HYDROCHLORIDE 5MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 38 · standardAP
2021-02-05Labeling · Supplement 37 · standardAP
2016-12-16Labeling · Supplement 36 · standardAP
1998-08-03Manufacturing (CMC) · Supplement 34AP
1998-08-03Manufacturing (CMC) · Supplement 35AP
1997-09-05Manufacturing (CMC) · Supplement 32AP
1997-09-05Manufacturing (CMC) · Supplement 33AP
1997-09-05Manufacturing (CMC) · Supplement 31AP
1997-03-26Manufacturing (CMC) · Supplement 30AP
1997-03-26Manufacturing (CMC) · Supplement 29AP
1993-06-22Labeling · Supplement 27AP
1988-10-05Manufacturing (CMC) · Supplement 20AP
1988-10-05Manufacturing (CMC) · Supplement 21AP
1988-08-22Manufacturing (CMC) · Supplement 24AP
1988-08-22Manufacturing (CMC) · Supplement 25AP
1988-08-22Manufacturing (CMC) · Supplement 23AP
1988-08-15Bioequivalence · Supplement 26AP
1988-06-10Labeling · Supplement 19AP
1986-01-17Manufacturing (CMC) · Supplement 16AP
1986-01-17Manufacturing (CMC) · Supplement 14AP
1986-01-17Manufacturing (CMC) · Supplement 15AP
1978-09-08OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.