APPLICATION
ANDA084768
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 5MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 95 · standardAP
2021-02-05Labeling · Supplement 93 · standardAP
2016-12-16Labeling · Supplement 89 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 85AP
2000-06-23Manufacturing (CMC) · Supplement 84AP
2000-06-23Manufacturing (CMC) · Supplement 83AP
1999-12-21Manufacturing (CMC) · Supplement 81AP
1999-05-20Manufacturing (CMC) · Supplement 79AP
1999-05-13Manufacturing (CMC) · Supplement 80AP
1998-12-01Manufacturing (CMC) · Supplement 77AP
1998-11-16Manufacturing (CMC) · Supplement 78AP
1997-04-16Manufacturing (CMC) · Supplement 76AP
1994-12-23Manufacturing (CMC) · Supplement 75AP
1993-08-02Labeling · Supplement 74AP
1992-05-01Manufacturing (CMC) · Supplement 70AP
1992-04-03Manufacturing (CMC) · Supplement 73AP
1992-04-03Manufacturing (CMC) · Supplement 71AP
1989-05-10Labeling · Supplement 69AP
1987-07-17Manufacturing (CMC) · Supplement 66AP
1987-07-17Manufacturing (CMC) · Supplement 67AP
1987-03-20Manufacturing (CMC) · Supplement 65AP
1985-11-12Manufacturing (CMC) · Supplement 58AP
1985-11-12Manufacturing (CMC) · Supplement 60AP
1985-11-12Manufacturing (CMC) · Supplement 59AP
1985-11-12Manufacturing (CMC) · Supplement 57AP
1982-06-07Manufacturing (CMC) · Supplement 39AP
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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