← FDA DRUG APPROVALS

FDA NDA · NDA020813

KLONOPIN RAPIDLY DISINTEGRATING

Sponsor: ROCHE

APPLICATION
NDA020813
TYPE
NDA
ORIGINAL APPROVAL
1997-12-23
LATEST ACTION
2016-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

KLONOPIN RAPIDLY DISINTEGRATING · ReferenceDiscontinued
CLONAZEPAM 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
KLONOPIN RAPIDLY DISINTEGRATING · ReferenceDiscontinued
CLONAZEPAM 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
KLONOPIN RAPIDLY DISINTEGRATING · ReferenceDiscontinued
CLONAZEPAM 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
KLONOPIN RAPIDLY DISINTEGRATING · ReferenceDiscontinued
CLONAZEPAM 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
KLONOPIN RAPIDLY DISINTEGRATING · ReferenceDiscontinued
CLONAZEPAM 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2016-12-16Labeling · Supplement 10 · standard — Label ↗AP
2013-10-31Labeling · Supplement 9 · standard — Letter ↗AP
2011-11-29REMS · Supplement 8 — Letter ↗AP
2010-09-01Labeling · Supplement 6 · standard — Label ↗AP
2010-09-01Labeling · Supplement 7 · standard — Letter ↗AP
2009-04-23Labeling · Supplement 5 · 901 required — Label ↗AP
2001-12-03Manufacturing (CMC) · Supplement 2 · standardAP
2001-07-31Manufacturing (CMC) · Supplement 1 · standardAP
1997-12-23Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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