← FDA DRUG APPROVALS

FDA NDA · NDA020865

MAXALT-MLT

rizatriptan benzoate

Sponsor: ORGANON

APPLICATION
NDA020865
TYPE
NDA
ORIGINAL APPROVAL
1998-06-29
LATEST ACTION
2019-10-01
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription, Discontinued

Products

MAXALT-MLT · ReferencePrescription
RIZATRIPTAN BENZOATE EQ 10MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL
MAXALT-MLT · ReferenceDiscontinued
RIZATRIPTAN BENZOATE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2019-10-01Labeling · Supplement 24 · standard — Label ↗AP
2014-05-29Manufacturing (CMC) · Supplement 22 · standardAP
2011-12-16Labeling · Supplement 21 · standard — Label ↗AP
2011-12-16Labeling · Supplement 18 · standard — Letter ↗AP
2011-12-16Labeling · Supplement 16 · standard — Label ↗AP
2011-12-16Efficacy · Supplement 20 · priority — Label ↗AP
2011-12-16Labeling · Supplement 12 · standard — Label ↗AP
2010-08-12Labeling · Supplement 14 · standard — Label ↗AP
2002-04-22Labeling · Supplement 9 · standard — Letter ↗AP
2001-12-06Manufacturing (CMC) · Supplement 10 · standardAP
2001-03-23Manufacturing (CMC) · Supplement 8 · standardAP
2000-12-11Labeling · Supplement 7 · standard — Review ↗AP
2000-12-11Labeling · Supplement 5 · standard — Review ↗AP
2000-12-11Efficacy · Supplement 6 · standard — Review ↗AP
2000-06-21Efficacy · Supplement 4 · standard — Review ↗AP
2000-06-21Supplement · Supplement 2 · standard — Review ↗AP
2000-03-28Manufacturing (CMC) · Supplement 3 · standardAP
1999-11-16Efficacy · Supplement 1 · standard — Letter ↗AP
1998-06-29Type 3 - New Dosage Form · Original · standard — Letter ↗AP
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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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