Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065228
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 500MG TABLET;ORAL Prescription AB No No
AMOXICILLIN AMOXICILLIN 875MG TABLET;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
07/13/2005 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
11/25/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

02/22/2013 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

AMOXICILLIN

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AMOXICILLIN 500MG TABLET;ORAL Prescription No AB 065256 AUROBINDO
AMOXICILLIN AMOXICILLIN 500MG TABLET;ORAL Prescription No AB 065228 SANDOZ
AMOXICILLIN AMOXICILLIN 500MG TABLET;ORAL Prescription No AB 065056 TEVA

TABLET;ORAL; 875MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AMOXICILLIN 875MG TABLET;ORAL Prescription No AB 065256 AUROBINDO
AMOXICILLIN AMOXICILLIN 875MG TABLET;ORAL Prescription No AB 065255 HIKMA
AMOXICILLIN AMOXICILLIN 875MG TABLET;ORAL Prescription No AB 065228 SANDOZ
AMOXICILLIN AMOXICILLIN 875MG TABLET;ORAL Prescription No AB 065056 TEVA

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