APPLICATION
NDA012249
TYPE
NDA
ORIGINAL APPROVAL
1960-02-24
LATEST ACTION
2016-12-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
LIBRIUM · ReferenceDiscontinued
CHLORDIAZEPOXIDE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
LIBRIUM · ReferenceDiscontinued
CHLORDIAZEPOXIDE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
LIBRIUM · ReferenceDiscontinued
CHLORDIAZEPOXIDE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
1983-06-02Manufacturing (CMC) · Supplement 47 · priorityAP
1982-01-26Manufacturing (CMC) · Supplement 45 · priorityAP
1982-01-26Manufacturing (CMC) · Supplement 44 · priorityAP
1980-06-03Labeling · Supplement 43AP
1979-10-25Labeling · Supplement 42AP
1978-07-24Manufacturing (CMC) · Supplement 41 · priorityAP
1978-03-31Labeling · Supplement 40AP
1977-02-18Manufacturing (CMC) · Supplement 39 · priorityAP
1977-02-18Manufacturing (CMC) · Supplement 38 · priorityAP
1976-12-14Labeling · Supplement 36AP
1976-10-18Labeling · Supplement 35AP
1974-04-29Manufacturing (CMC) · Supplement 26 · priorityAP
1960-02-24Type 1 - New Molecular Entity · Original · priorityAP
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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