APPLICATION
ANDA084679
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 25MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 88 · standardAP
2016-12-16Labeling · Supplement 85 · standardAP
1995-02-03Labeling · Supplement 81AP
1989-04-07Labeling · Supplement 79AP
1987-07-23Manufacturing (CMC) · Supplement 76AP
1987-07-23Manufacturing (CMC) · Supplement 77AP
1987-07-23Manufacturing (CMC) · Supplement 75AP
1985-01-08Manufacturing (CMC) · Supplement 73AP
1984-05-25Manufacturing (CMC) · Supplement 71AP
1984-01-13Manufacturing (CMC) · Supplement 70AP
1984-01-13Manufacturing (CMC) · Supplement 69AP
1983-06-20Manufacturing (CMC) · Supplement 68AP
1982-07-22Manufacturing (CMC) · Supplement 63AP
1982-07-01Manufacturing (CMC) · Supplement 62AP
1982-03-15Manufacturing (CMC) · Supplement 58AP
1982-03-15Manufacturing (CMC) · Supplement 56AP
1982-03-15Manufacturing (CMC) · Supplement 60AP
1982-03-15Manufacturing (CMC) · Supplement 59AP
1982-03-15Manufacturing (CMC) · Supplement 57AP
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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