APPLICATION
ANDA074569
TYPE
ANDA
ORIGINAL APPROVAL
1996-09-10
LATEST ACTION
2016-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLONAZEPAMPrescription
CLONAZEPAM 1MG · TABLET · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 2MG · TABLET · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 0.5MG · TABLET · ORAL
Approval history
2016-07-18Labeling · Supplement 41 · standardAP
2012-07-19REMS · Supplement 40AP
2011-04-08Labeling · Supplement 37AP
2011-04-08REMS · Supplement 38AP
2009-10-15Labeling · Supplement 32AP
2009-10-15Labeling · Supplement 33AP
2009-05-07Labeling · Supplement 31AP
2001-10-16Labeling · Supplement 19AP
2000-10-13Labeling · Supplement 18AP
1999-12-02Manufacturing (CMC) · Supplement 16AP
1999-12-02Manufacturing (CMC) · Supplement 17AP
1999-02-12Manufacturing (CMC) · Supplement 10AP
1999-02-12Manufacturing (CMC) · Supplement 9AP
1998-10-08Manufacturing (CMC) · Supplement 8AP
1998-06-22Manufacturing (CMC) · Supplement 6AP
1998-06-22Labeling · Supplement 7AP
1998-06-22Manufacturing (CMC) · Supplement 5AP
1998-02-18Labeling · Supplement 4AP
1998-01-28Manufacturing (CMC) · Supplement 1AP
1997-11-25Manufacturing (CMC) · Supplement 3AP
1997-07-16Manufacturing (CMC) · Supplement 2AP
1996-09-10OriginalAP
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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