APPLICATION
ANDA078654
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-27
LATEST ACTION
2023-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued
Products
CLONAZEPAMDiscontinued
CLONAZEPAM 2MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLONAZEPAMDiscontinued
CLONAZEPAM 0.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLONAZEPAMDiscontinued
CLONAZEPAM 0.125MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLONAZEPAMDiscontinued
CLONAZEPAM 1MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLONAZEPAMDiscontinued
CLONAZEPAM 0.25MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2023-05-01Manufacturing (CMC) · Supplement 11 · unknownAP
2023-01-17Labeling · Supplement 10 · standardAP
2021-02-05Labeling · Supplement 8 · standardAP
2021-01-21Labeling · Supplement 3 · standardAP
2016-12-16Labeling · Supplement 1 · standardAP
2014-08-27OriginalAP
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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