APPLICATION
ANDA074964
TYPE
ANDA
ORIGINAL APPROVAL
1997-12-30
LATEST ACTION
2015-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CLONAZEPAMDiscontinued
CLONAZEPAM 2MG · TABLET · ORAL
CLONAZEPAMDiscontinued
CLONAZEPAM 0.5MG · TABLET · ORAL
CLONAZEPAMDiscontinued
CLONAZEPAM 1MG · TABLET · ORAL
Approval history
2015-11-05Labeling · Supplement 18AP
2009-10-15Labeling · Supplement 15AP
2004-10-20Labeling · Supplement 7AP
2003-10-28Labeling · Supplement 5AP
2001-04-12Manufacturing (CMC) · Supplement 3AP
2000-12-22Labeling · Supplement 4AP
2000-03-21Manufacturing (CMC) · Supplement 2AP
1998-08-21Manufacturing (CMC) · Supplement 1AP
1997-12-30OriginalAP
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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