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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065322
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Prescription AB No No
AMOXICILLIN AMOXICILLIN 125MG/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
12/02/2014 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

03/07/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

10/30/2008 SUPPL-4 Labeling

Label is not available on this site.

AMOXICILLIN

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 062927 DAVA PHARMS INC
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

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 062927 DAVA PHARMS INC
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
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