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FDA ANDA · ANDA065043

CEFUROXIME AXETIL

Sponsor: RANBAXY LABS LTD

APPLICATION
ANDA065043
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-15
LATEST ACTION
2002-11-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CEFUROXIME AXETILDiscontinued
CEFUROXIME AXETIL EQ 250MG BASE · TABLET · ORAL
CEFUROXIME AXETILDiscontinued
CEFUROXIME AXETIL EQ 125MG BASE · TABLET · ORAL
CEFUROXIME AXETILDiscontinued
CEFUROXIME AXETIL EQ 500MG BASE · TABLET · ORAL

Approval history

2002-11-12Labeling · Supplement 4AP
2002-08-13Manufacturing (CMC) · Supplement 2AP
2002-08-13Manufacturing (CMC) · Supplement 3AP
2002-02-15Original — Letter ↗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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