APPLICATION
ANDA083116
TYPE
ANDA
ORIGINAL APPROVAL
1976-06-10
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CHLORDIAZEPOXIDE HYDROCHLORIDE · ReferencePrescription
CHLORDIAZEPOXIDE HYDROCHLORIDE 10MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 115 · standardAP
2021-02-05Labeling · Supplement 113 · standardAP
2016-12-16Labeling · Supplement 109 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 104AP
2001-11-02Manufacturing (CMC) · Supplement 102AP
2000-05-31Manufacturing (CMC) · Supplement 103AP
1999-12-21Manufacturing (CMC) · Supplement 101AP
1999-05-20Manufacturing (CMC) · Supplement 99AP
1999-05-13Manufacturing (CMC) · Supplement 100AP
1998-12-01Manufacturing (CMC) · Supplement 97AP
1998-11-16Manufacturing (CMC) · Supplement 98AP
1997-04-16Manufacturing (CMC) · Supplement 96AP
1994-12-23Manufacturing (CMC) · Supplement 95AP
1993-08-02Labeling · Supplement 94AP
1992-04-03Manufacturing (CMC) · Supplement 93AP
1992-04-03Manufacturing (CMC) · Supplement 91AP
1989-05-01Labeling · Supplement 90AP
1987-07-17Manufacturing (CMC) · Supplement 86AP
1985-11-19Manufacturing (CMC) · Supplement 79AP
1985-11-19Manufacturing (CMC) · Supplement 81AP
1985-11-19Manufacturing (CMC) · Supplement 78AP
1985-11-19Manufacturing (CMC) · Supplement 82AP
1985-11-19Manufacturing (CMC) · Supplement 80AP
1982-05-13Manufacturing (CMC) · Supplement 59AP
1982-03-29Manufacturing (CMC) · Supplement 68AP
1976-06-10OriginalAP
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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