APPLICATION
ANDA086294
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 10MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 41 · standardAP
2021-02-05Labeling · Supplement 40 · standardAP
2016-12-16Labeling · Supplement 39 · standardAP
1998-08-03Manufacturing (CMC) · Supplement 38AP
1998-08-03Manufacturing (CMC) · Supplement 37AP
1997-09-03Manufacturing (CMC) · Supplement 36AP
1997-09-03Manufacturing (CMC) · Supplement 34AP
1997-09-03Manufacturing (CMC) · Supplement 35AP
1997-03-25Manufacturing (CMC) · Supplement 32AP
1997-03-25Manufacturing (CMC) · Supplement 33AP
1994-01-28Manufacturing (CMC) · Supplement 28AP
1993-06-22Labeling · Supplement 30AP
1989-08-31Bioequivalence · Supplement 29AP
1989-01-26Manufacturing (CMC) · Supplement 21AP
1988-10-11Manufacturing (CMC) · Supplement 24AP
1988-10-11Manufacturing (CMC) · Supplement 25AP
1988-07-15Labeling · Supplement 23AP
1988-06-10Labeling · Supplement 42AP
1988-06-10Labeling · Supplement 22AP
1987-07-17Manufacturing (CMC) · Supplement 19AP
1986-01-17Manufacturing (CMC) · Supplement 16AP
1986-01-17Manufacturing (CMC) · Supplement 17AP
1986-01-17Manufacturing (CMC) · Supplement 15AP
1985-12-27Manufacturing (CMC) · Supplement 14AP
1984-02-09Manufacturing (CMC) · Supplement 9AP
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.