FDA NDA · NDA202091

SUPRAX

Sponsor: LUPIN LTD

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APPLICATION
NDA202091
TYPE
NDA
ORIGINAL APPROVAL
2013-02-20
LATEST ACTION
2026-10-15
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

SUPRAX · ReferencePrescription
CEFIXIME 500MG/5ML · FOR SUSPENSION · ORAL

Approval history

2026-10-15Labeling · Supplement 11 · standard — Letter ↗AP
2019-10-29Labeling · Supplement 9 · standard — Letter ↗AP
2018-03-30Labeling · Supplement 7 · standard — Letter ↗AP
2017-03-16Labeling · Supplement 5 · standard — Label ↗AP
2016-05-10Manufacturing (CMC) · Supplement 3 · standardAP
2016-01-07Labeling · Supplement 4 · standard — Label ↗AP
2014-05-29Labeling · Supplement 2 · standard — Letter ↗AP
2014-01-16Manufacturing (CMC) · Supplement 1 · standardAP
2013-02-20Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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