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FDA NDA · NDA203195

CEFIXIME

Sponsor: LUPIN LTD

APPLICATION
NDA203195
TYPE
NDA
ORIGINAL APPROVAL
2012-06-01
LATEST ACTION
2025-05-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

SUPRAX · ReferencePrescription
CEFIXIME 400MG · CAPSULE · ORAL

Approval history

2025-05-22Labeling · Supplement 13 · standard — Letter ↗AP
2018-06-29Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP
2018-03-30Labeling · Supplement 8 · standard — Letter ↗AP
2017-03-16Labeling · Supplement 6 · standard — Label ↗AP
2016-01-07Labeling · Supplement 5 · standard — Label ↗AP
2013-11-22Manufacturing (CMC) · Supplement 3 · standardAP
2013-09-18Manufacturing (CMC) · Supplement 2 · standardAP
2013-03-26Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2012-06-01Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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