Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065109
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 500MG;EQ 125MG BASE TABLET;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
11/04/2002 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
10/28/2008 SUPPL-16 Labeling

Label is not available on this site.

03/28/2007 SUPPL-14 Labeling

Label is not available on this site.

02/02/2006 SUPPL-8 Labeling

Label is not available on this site.

09/30/2004 SUPPL-6 Labeling

Label is not available on this site.

05/14/2004 SUPPL-4 Labeling

Label is not available on this site.

05/25/2004 SUPPL-3 Labeling

Label is not available on this site.

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