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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065189
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET;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
08/23/2005 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/065189_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/22/2014 SUPPL-16 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/22/2014 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

09/22/2014 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

09/26/2006 SUPPL-6 Labeling

Label is not available on this site.

07/31/2006 SUPPL-4 Labeling

Label is not available on this site.

AMOXICILLIN AND CLAVULANATE POTASSIUM

TABLET;ORAL; 250MG;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 250MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 091569 AUROBINDO PHARMA LTD
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 205707 MICRO LABS LTD INDIA
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065189 SANDOZ
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