Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065162
Company: TEVA
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/12/2004 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065162_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

03/05/2009 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065162s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065162s021ltr.pdf
09/08/2006 SUPPL-16 Labeling

Label is not available on this site.

10/17/2005 SUPPL-13 Labeling

Label is not available on this site.

02/17/2015 SUPPL-8 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/05/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065162s021lbl.pdf

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 EU OPERATN

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