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FDA ANDA · ANDA085461

CHLORDIAZEPOXIDE HYDROCHLORIDE

Sponsor: BAUSCH

APPLICATION
ANDA085461
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 5MG · CAPSULE · ORAL

Approval history

2023-01-17Labeling · Supplement 58 · standardAP
2021-02-05Labeling · Supplement 56 · standardAP
2016-12-16Labeling · Supplement 55 · standardAP
2002-09-26Manufacturing (CMC) · Supplement 49AP
2002-09-26Manufacturing (CMC) · Supplement 47AP
2002-09-26Manufacturing (CMC) · Supplement 45AP
2002-09-26Manufacturing (CMC) · Supplement 48AP
2002-09-26Manufacturing (CMC) · Supplement 46AP
2002-09-26Manufacturing (CMC) · Supplement 44AP
2002-09-26Labeling · Supplement 50AP
1997-11-28Manufacturing (CMC) · Supplement 42AP
1997-10-20Manufacturing (CMC) · Supplement 43AP
1994-11-03Labeling · Supplement 41AP
1991-03-27Manufacturing (CMC) · Supplement 40AP
1989-04-07Manufacturing (CMC) · Supplement 37AP
1989-02-06Labeling · Supplement 39AP
1988-04-01Labeling · Supplement 36AP
1987-11-02Manufacturing (CMC) · Supplement 35AP
1984-06-07Manufacturing (CMC) · Supplement 33AP
1983-06-09Manufacturing (CMC) · Supplement 32AP
1982-07-14Manufacturing (CMC) · Supplement 31AP
1982-05-14Manufacturing (CMC) · Supplement 29AP
1982-04-01Manufacturing (CMC) · Supplement 28AP
1977-09-21OriginalAP
VIEW ON DRUGS@FDA ↗

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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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