APPLICATION
ANDA086382
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 25MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 35 · standardAP
2021-02-05Labeling · Supplement 34 · standardAP
2016-12-16Labeling · Supplement 33 · standardAP
1998-08-03Manufacturing (CMC) · Supplement 31AP
1998-08-03Manufacturing (CMC) · Supplement 32AP
1997-09-24Manufacturing (CMC) · Supplement 29AP
1997-09-24Manufacturing (CMC) · Supplement 30AP
1997-03-26Manufacturing (CMC) · Supplement 27AP
1997-03-26Manufacturing (CMC) · Supplement 28AP
1993-06-22Labeling · Supplement 24AP
1988-10-11Manufacturing (CMC) · Supplement 23AP
1988-10-11Manufacturing (CMC) · Supplement 21AP
1988-10-11Manufacturing (CMC) · Supplement 22AP
1988-08-24Bioequivalence · Supplement 26AP
1988-07-15Labeling · Supplement 20AP
1988-06-10Labeling · Supplement 19AP
1987-07-17Manufacturing (CMC) · Supplement 17AP
1986-01-17Manufacturing (CMC) · Supplement 15AP
1986-01-17Manufacturing (CMC) · Supplement 13AP
1986-01-17Manufacturing (CMC) · Supplement 14AP
1986-01-03Manufacturing (CMC) · Supplement 12AP
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.
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