APPLICATION
ANDA085472
TYPE
ANDA
ORIGINAL APPROVAL
1977-09-21
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
LIBRIUM · ReferencePrescription
CHLORDIAZEPOXIDE HYDROCHLORIDE 10MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 50 · standardAP
2021-02-05Labeling · Supplement 48 · standardAP
2016-12-16Labeling · Supplement 47 · standardAP
2002-09-26Manufacturing (CMC) · Supplement 42AP
2002-09-26Manufacturing (CMC) · Supplement 40AP
2002-09-26Labeling · Supplement 43AP
2002-09-26Manufacturing (CMC) · Supplement 41AP
1997-11-28Manufacturing (CMC) · Supplement 38AP
1997-10-20Manufacturing (CMC) · Supplement 39AP
1994-11-03Labeling · Supplement 37AP
1991-03-27Manufacturing (CMC) · Supplement 36AP
1989-02-06Labeling · Supplement 35AP
1988-04-01Labeling · Supplement 33AP
1987-11-02Manufacturing (CMC) · Supplement 32AP
1984-06-07Manufacturing (CMC) · Supplement 30AP
1983-06-09Manufacturing (CMC) · Supplement 29AP
1982-07-14Manufacturing (CMC) · Supplement 28AP
1982-05-14Manufacturing (CMC) · Supplement 26AP
1982-03-30Manufacturing (CMC) · Supplement 25AP
1977-09-21OriginalAP
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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