APPLICATION
ANDA074869
TYPE
ANDA
ORIGINAL APPROVAL
1996-10-31
LATEST ACTION
2024-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLONAZEPAMPrescription
CLONAZEPAM 2MG · TABLET · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 0.5MG · TABLET · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 1MG · TABLET · ORAL
Approval history
2024-06-12Labeling · Supplement 38 · standardAP
2024-06-12Labeling · Supplement 42 · standardAP
2024-06-12Labeling · Supplement 37 · standardAP
2024-06-12Labeling · Supplement 43 · standardAP
2013-04-03Labeling · Supplement 29AP
2011-04-08Labeling · Supplement 27AP
2009-10-15Labeling · Supplement 25AP
2001-11-02Manufacturing (CMC) · Supplement 7AP
2001-10-05Labeling · Supplement 8AP
2001-04-27Manufacturing (CMC) · Supplement 6AP
2000-08-25Labeling · Supplement 5AP
1999-03-12Manufacturing (CMC) · Supplement 4AP
1998-11-24Manufacturing (CMC) · Supplement 3AP
1997-11-10Labeling · Supplement 2AP
1997-05-23Manufacturing (CMC) · Supplement 1AP
1996-10-31OriginalAP
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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