Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065161
Company: SUN PHARM INDS LTD
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
12/03/2003 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065161_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/28/2008 SUPPL-8 Labeling

Label is not available on this site.

10/26/2007 SUPPL-4 Labeling

Label is not available on this site.

03/08/2006 SUPPL-2 Labeling

Label is not available on this site.

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