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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065282
Company: TEVA PHARMS

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 Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/20/2006 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
07/17/2008 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 065392 LUPIN
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065282 TEVA PHARMS
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