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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065358
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 600MG/5ML;EQ 42.9MG BASE/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
08/13/2007 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
01/27/2020 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/30/2012 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

10/29/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

AMOXICILLIN AND CLAVULANATE POTASSIUM

FOR SUSPENSION;ORAL; 600MG/5ML;EQ 42.9MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 201091 AUROBINDO PHARMA LTD
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065373 HIKMA PHARMS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065358 SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065162 TEVA
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065420 WOCKHARDT BIO AG
AUGMENTIN ES-600 AMOXICILLIN; CLAVULANATE POTASSIUM 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050755 US ANTIBIOTICS
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