APPLICATION
NDA012301
TYPE
NDA
ORIGINAL APPROVAL
1961-07-21
LATEST ACTION
2002-05-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LIBRIUMDiscontinued
CHLORDIAZEPOXIDE HYDROCHLORIDE 100MG/AMP · INJECTABLE · INJECTION
Approval history
1998-12-28Manufacturing (CMC) · Supplement 24 · standardAP
1994-02-03Manufacturing (CMC) · Supplement 22 · standardAP
1992-07-16Manufacturing (CMC) · Supplement 21 · standardAP
1985-08-06Manufacturing (CMC) · Supplement 19 · standardAP
1985-05-29Manufacturing (CMC) · Supplement 18 · standardAP
1985-03-29Labeling · Supplement 17AP
1983-02-03Manufacturing (CMC) · Supplement 16 · standardAP
1980-08-21Labeling · Supplement 14AP
1980-05-28Labeling · Supplement 13AP
1979-10-25Labeling · Supplement 12AP
1979-07-20Labeling · Supplement 11AP
1978-11-06Labeling · Supplement 10AP
1977-12-14Labeling · Supplement 8AP
1961-07-21Type 3 - New Dosage Form · Original · standardAP
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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