APPLICATION
ANDA084041
TYPE
ANDA
ORIGINAL APPROVAL
1976-06-15
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CHLORDIAZEPOXIDE HYDROCHLORIDEPrescription
CHLORDIAZEPOXIDE HYDROCHLORIDE 10MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 101 · standardAP
2016-12-16Labeling · Supplement 98 · standardAP
1995-02-03Labeling · Supplement 94AP
1989-11-03Labeling · Supplement 92AP
1989-05-01Labeling · Supplement 91AP
1985-01-08Manufacturing (CMC) · Supplement 89AP
1984-05-25Manufacturing (CMC) · Supplement 86AP
1984-01-13Manufacturing (CMC) · Supplement 84AP
1984-01-13Manufacturing (CMC) · Supplement 85AP
1983-06-21Manufacturing (CMC) · Supplement 82AP
1982-08-17Manufacturing (CMC) · Supplement 78AP
1982-08-17Manufacturing (CMC) · Supplement 79AP
1982-06-28Manufacturing (CMC) · Supplement 77AP
1982-05-27Manufacturing (CMC) · Supplement 74AP
1982-03-15Manufacturing (CMC) · Supplement 73AP
1982-03-15Manufacturing (CMC) · Supplement 71AP
1982-03-15Manufacturing (CMC) · Supplement 68AP
1982-03-15Manufacturing (CMC) · Supplement 70AP
1982-03-15Manufacturing (CMC) · Supplement 69AP
1976-06-15OriginalAP
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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