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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090227
Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 1GM;EQ 62.5MG BASE TABLET, EXTENDED RELEASE;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
04/21/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090227s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/01/2024 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
04/30/2024 SUPPL-18 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
01/05/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
01/16/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
09/04/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

AMOXICILLIN AND CLAVULANATE POTASSIUM

TABLET, EXTENDED RELEASE;ORAL; 1GM;EQ 62.5MG 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 1GM;EQ 62.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090227 SANDOZ
AUGMENTIN XR AMOXICILLIN; CLAVULANATE POTASSIUM 1GM;EQ 62.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 050785 US ANTIBIOTICS
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