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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065334
Company: AUROBINDO

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 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
12/28/2006 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
09/17/2025 SUPPL-26 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
05/01/2024 SUPPL-25 Labeling-Package Insert

Label is not available on this site.
04/09/2024 SUPPL-20 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
04/09/2024 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
04/09/2024 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
04/09/2024 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
12/03/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
11/26/2012 SUPPL-2 Labeling

Label is not available on this site.

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 065319 CHARTWELL RX
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
AMOXIL AMOXICILLIN 400MG/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050760 US ANTIBIOTICS
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