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FDA NDA · NDA017533

KLONOPIN

clonazepam

Sponsor: CHEPLAPHARM

APPLICATION
NDA017533
TYPE
NDA
ORIGINAL APPROVAL
1975-06-04
LATEST ACTION
2023-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

KLONOPINDiscontinued
CLONAZEPAM 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
KLONOPIN · ReferencePrescription
CLONAZEPAM 1MG · TABLET · ORAL
KLONOPINDiscontinued
CLONAZEPAM 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
KLONOPIN · ReferencePrescription
CLONAZEPAM 2MG · TABLET · ORAL
KLONOPIN · ReferencePrescription
CLONAZEPAM 0.5MG · TABLET · ORAL

Approval history

2023-01-13Labeling · Supplement 62 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 61 · standard — Letter ↗AP
2017-10-25Labeling · Supplement 59 · standard — Label ↗AP
2016-12-16Labeling · Supplement 58 · standard — Label ↗AP
2016-11-02Manufacturing (CMC) · Supplement 57 · standardAP
2016-06-13Manufacturing (CMC) · Supplement 56 · priorityAP
2016-03-25Labeling · Supplement 55 · standard — Letter ↗AP
2015-02-03Manufacturing (CMC) · Supplement 54 · priorityAP
2013-10-31Labeling · Supplement 53 · standard — Letter ↗AP
2011-11-29REMS · Supplement 52 — Letter ↗AP
2010-09-01Labeling · Supplement 48 · unknown — Letter ↗AP
2010-09-01Labeling · Supplement 46 · standard — Letter ↗AP
2009-04-23Labeling · Supplement 45 · 901 required — Letter ↗AP
2002-03-15Manufacturing (CMC) · Supplement 39 · priorityAP
2002-03-11Manufacturing (CMC) · Supplement 38 · priorityAP
2002-01-29Labeling · Supplement 37 · standard — Review ↗AP
2001-11-07Manufacturing (CMC) · Supplement 36 · priorityAP
2001-09-10Manufacturing (CMC) · Supplement 35 · priorityAP
2001-04-11Labeling · Supplement 31 · standard — Letter ↗AP
2001-01-22Manufacturing (CMC) · Supplement 34 · priorityAP
2000-03-28Manufacturing (CMC) · Supplement 33 · priorityAP
1999-10-18Manufacturing (CMC) · Supplement 32 · priorityAP
1997-12-30Manufacturing (CMC) · Supplement 30 · priorityAP
1997-09-19Manufacturing (CMC) · Supplement 29 · priorityAP
1997-04-09Efficacy · Supplement 23 · standardAP
1997-03-07Manufacturing (CMC) · Supplement 28 · priorityAP
1996-11-20Manufacturing (CMC) · Supplement 27 · priorityAP
1996-10-17Manufacturing (CMC) · Supplement 26 · priorityAP
1996-08-30Manufacturing (CMC) · Supplement 25 · priorityAP
1996-06-18Manufacturing (CMC) · Supplement 24 · priorityAP
1994-07-01Manufacturing (CMC) · Supplement 22 · priorityAP
1993-06-03Manufacturing (CMC) · Supplement 21 · priorityAP
1993-06-03Manufacturing (CMC) · Supplement 20 · priorityAP
1993-05-28Manufacturing (CMC) · Supplement 18 · priorityAP
1993-04-30Labeling · Supplement 19AP
1993-04-30Labeling · Supplement 17AP
1990-07-19Manufacturing (CMC) · Supplement 15 · priorityAP
1990-07-19Labeling · Supplement 16AP
1987-05-01Manufacturing (CMC) · Supplement 14 · priorityAP
1985-12-13Labeling · Supplement 13AP
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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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