Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065066
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION;ORAL Prescription AB No No
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG 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
06/05/2002 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065066.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/22/2014 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

09/22/2014 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

09/22/2014 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

06/28/2011 SUPPL-28 Labeling

Label is not available on this site.

05/29/2009 SUPPL-23 Labeling

Label is not available on this site.

11/25/2014 SUPPL-19 Labeling

Label is not available on this site.

01/14/2007 SUPPL-18 Labeling

Label is not available on this site.

06/02/2005 SUPPL-10 Labeling

Label is not available on this site.

11/26/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

AMOXICILLIN AND CLAVULANATE POTASSIUM

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 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

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 065191 HIKMA PHARMS
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

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