Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065119
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 200MG/5ML FOR SUSPENSION;ORAL Prescription AB No No
AMOXICILLIN AMOXICILLIN 400MG/5ML FOR SUSPENSION;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
12/04/2002 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
11/20/2012 SUPPL-20 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065119s020lbl.pdf
11/26/2012 SUPPL-18 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/10/2011 SUPPL-15 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/20/2012 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065119s020lbl.pdf

AMOXICILLIN

FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AMOXICILLIN 200MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065334 AUROBINDO
AMOXICILLIN AMOXICILLIN 200MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065325 HIKMA
AMOXICILLIN AMOXICILLIN 200MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065378 SANDOZ
AMOXICILLIN AMOXICILLIN 200MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065119 TEVA

FOR SUSPENSION;ORAL; 400MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AMOXICILLIN 400MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065334 AUROBINDO
AMOXICILLIN AMOXICILLIN 400MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065325 HIKMA
AMOXICILLIN AMOXICILLIN 400MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065378 SANDOZ
AMOXICILLIN AMOXICILLIN 400MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065119 TEVA
AMOXICILLIN AMOXICILLIN 400MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065319 WOCKHARDT

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