Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062059
Company: AM ANTIBIOTICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 125MG/5ML FOR SUSPENSION;ORAL Discontinued None No No
AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION;ORAL Discontinued None 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
12/08/1978 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
01/26/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

07/15/1997 SUPPL-1 Labeling

Label is not available on this site.

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