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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204030
Company: AUROBINDO PHARMA LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription AB No No
AMOXICILLIN AMOXICILLIN 250MG/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
09/15/2014 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
05/01/2024 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
04/12/2024 SUPPL-10 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
05/29/2020 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
05/29/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
05/29/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

AMOXICILLIN

FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 204030 AUROBINDO PHARMA LTD
AMOXICILLIN AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065322 HIKMA
AMOXICILLIN AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065387 SANDOZ
AMOXIL AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 062226 US ANTIBIOTICS
LAROTID AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 062226 US ANTIBIOTICS

FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 204030 AUROBINDO PHARMA LTD
AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065322 HIKMA
AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065387 SANDOZ
AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 061931 TEVA
AMOXIL AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 062226 US ANTIBIOTICS
LAROTID AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 062226 US ANTIBIOTICS
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