Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065096
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;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
10/29/2002 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
11/04/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/26/2014 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

07/08/2013 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

04/26/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

06/09/2011 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

02/02/2009 SUPPL-19 Labeling

Label is not available on this site.

02/02/2007 SUPPL-17 Labeling

Label is not available on this site.

04/06/2006 SUPPL-14 Labeling

Label is not available on this site.

07/02/2004 SUPPL-9 Labeling

Label is not available on this site.

11/13/2003 SUPPL-8 Labeling

Label is not available on this site.

07/08/2003 SUPPL-7 Labeling

Label is not available on this site.

AMOXICILLIN AND CLAVULANATE POTASSIUM

TABLET;ORAL; 875MG;EQ 125MG BASE
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 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 091568 AUROBINDO PHARMA LTD
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 203824 HIKMA PHARMS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 204755 MICRO LABS LTD INDIA
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065063 SANDOZ
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065093 SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065096 TEVA PHARMS USA
AUGMENTIN '875' AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription Yes AB 050720 DR REDDYS LABS INC

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