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FDA NDA · NDA021016

RELPAX

eletriptan hydrobromide

Sponsor: UPJOHN

APPLICATION
NDA021016
TYPE
NDA
ORIGINAL APPROVAL
2002-12-26
LATEST ACTION
2020-03-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

RELPAX · ReferencePrescription
ELETRIPTAN HYDROBROMIDE EQ 20MG BASE · TABLET · ORAL
RELPAX · ReferencePrescription
ELETRIPTAN HYDROBROMIDE EQ 40MG BASE · TABLET · ORAL

Approval history

2020-03-24Labeling · Supplement 29 · standard — Label ↗AP
2015-09-18Manufacturing (CMC) · Supplement 28 · standardAP
2013-12-03Manufacturing (CMC) · Supplement 26 · standardAP
2013-11-07Manufacturing (CMC) · Supplement 25 · standardAP
2013-10-03Labeling · Supplement 27 · standard — Letter ↗AP
2013-10-03Labeling · Supplement 23 · standard — Letter ↗AP
2013-10-03Labeling · Supplement 21 · unknown — Label ↗AP
2013-10-03Labeling · Supplement 24 · standard — Letter ↗AP
2011-04-13Labeling · Supplement 18 · standard — Letter ↗AP
2010-07-21Labeling · Supplement 16 · standard — Label ↗AP
2010-07-21Labeling · Supplement 9 · standard — Letter ↗AP
2005-07-27Labeling · Supplement 6 · standardAP
2004-05-06Labeling · Supplement 3 · standard — Letter ↗AP
2002-12-26Type 1 - New Molecular Entity · Original · standard — Label ↗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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