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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065191
Company: HIKMA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION;ORAL Prescription AB No No
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG 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
01/25/2005 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.
04/23/2024 SUPPL-32 Labeling-Package Insert

Label is not available on this site.
11/03/2014 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
11/03/2014 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
01/27/2011 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
08/31/2009 SUPPL-7 Labeling

Label is not available on this site.
01/27/2011 SUPPL-6 Labeling

Label is not available on this site.

AMOXICILLIN AND CLAVULANATE POTASSIUM

FOR SUSPENSION;ORAL; 400MG/5ML;EQ 57MG 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 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 201090 AUROBINDO PHARMA LTD
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 210416 DEVA HOLDING AS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065191 HIKMA PHARMS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 205187 MICRO LABS LTD INDIA
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065066 SANDOZ
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065098 SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065089 TEVA

FOR SUSPENSION;ORAL; 200MG/5ML;EQ 28.5MG 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 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 201090 AUROBINDO PHARMA LTD
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065191 HIKMA PHARMS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 205187 MICRO LABS LTD INDIA
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065066 SANDOZ
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065098 SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065089 TEVA
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