Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065392
Company: LUPIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE CAPSULE;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
05/29/2007 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
12/13/2007 SUPPL-1 Labeling

Label is not available on this site.

CEFADROXIL

CAPSULE;ORAL; EQ 500MG BASE
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 CAPSULE;ORAL Prescription No AB 065352 AUROBINDO PHARMA
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065311 HIKMA
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065392 LUPIN
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065309 ORCHID HLTHCARE
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065282 TEVA PHARMS

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