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FDA ANDA · ANDA065396

CEFADROXIL

Sponsor: LUPIN

APPLICATION
ANDA065396
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-21
LATEST ACTION
2014-04-18
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

CEFADROXILPrescription
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML · FOR SUSPENSION · ORAL
CEFADROXILPrescription
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML · FOR SUSPENSION · ORAL

Approval history

2014-04-18Labeling · Supplement 12 · standard — Label ↗AP
2008-02-21Original — 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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