Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065065
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 200MG;EQ 28.5MG BASE TABLET, CHEWABLE;ORAL Discontinued None No No
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 400MG;EQ 57MG BASE TABLET, CHEWABLE;ORAL Discontinued None 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
04/18/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65065ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/22/2014 SUPPL-30 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.

09/22/2014 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

06/28/2011 SUPPL-25 Labeling

Label is not available on this site.

05/29/2009 SUPPL-22 Labeling

Label is not available on this site.

01/31/2008 SUPPL-19 Labeling

Label is not available on this site.

01/03/2007 SUPPL-18 Labeling

Label is not available on this site.

06/02/2005 SUPPL-12 Labeling

Label is not available on this site.

09/13/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/21/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-2 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/21/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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