APPLICATION
ANDA072112
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-26
LATEST ACTION
2016-12-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
CLORAZEPATE DIPOTASSIUMDiscontinued
CLORAZEPATE DIPOTASSIUM 3.75MG · CAPSULE · ORAL
CLORAZEPATE DIPOTASSIUMDiscontinued
CLORAZEPATE DIPOTASSIUM 7.5MG · CAPSULE · ORAL
CLORAZEPATE DIPOTASSIUMDiscontinued
CLORAZEPATE DIPOTASSIUM 15MG · CAPSULE · ORAL
Approval history
2016-12-16Labeling · Supplement 10 · standardAP
2000-03-09Manufacturing (CMC) · Supplement 5AP
2000-03-09Manufacturing (CMC) · Supplement 6AP
1999-09-29Labeling · Supplement 4AP
1990-09-05Labeling · Supplement 1AP
1988-08-26OriginalAP
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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