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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065325
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 400MG/5ML FOR SUSPENSION;ORAL Prescription AB No No
AMOXICILLIN AMOXICILLIN 200MG/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
06/19/2006 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
05/01/2024 SUPPL-35 Labeling-Package Insert

Label is not available on this site.
04/25/2024 SUPPL-32 Labeling-Package Insert

Label is not available on this site.
12/02/2014 SUPPL-17 Labeling-Package Insert

Label is not available on this site.
12/02/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
03/07/2013 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
10/30/2008 SUPPL-3 Labeling

Label is not available on this site.

AMOXICILLIN

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 BIO AG
AMOXIL AMOXICILLIN 400MG/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050760 US ANTIBIOTICS

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
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