Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065349
Company: AUROBINDO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription AB No No
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/25/2013 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/18/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

CEFADROXIL

FOR SUSPENSION;ORAL; EQ 250MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065349 AUROBINDO
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 091036 HIKMA PHARMS
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065396 LUPIN
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065307 ORCHID HLTHCARE

FOR SUSPENSION;ORAL; EQ 500MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065349 AUROBINDO
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 091036 HIKMA PHARMS
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065396 LUPIN
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065307 ORCHID HLTHCARE

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