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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065063
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;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
03/14/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65063ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/01/2022 SUPPL-46 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/22/2014 SUPPL-35 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

09/22/2014 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

09/22/2014 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

09/26/2006 SUPPL-23 Labeling

Label is not available on this site.

07/31/2006 SUPPL-22 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.

AMOXICILLIN AND CLAVULANATE POTASSIUM

TABLET;ORAL; 875MG;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 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 091568 AUROBINDO PHARMA LTD
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 203824 HIKMA PHARMS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 204755 MICRO LABS LTD INDIA
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065063 SANDOZ
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065093 SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065096 TEVA PHARMS USA
AUGMENTIN '875' AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription Yes AB 050720 US ANTIBIOTICS
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