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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065319
Company: CHARTWELL RX

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/18/2007 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
01/14/2021 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
01/14/2021 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
12/02/2014 SUPPL-1 Labeling-Package Insert

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 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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