Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065064
Company: SANDOZ

Products on ANDA 065064

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	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065064

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/15/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65064ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2024	SUPPL-50	Labeling-Package Insert		Label is not available on this site.
04/29/2024	SUPPL-47	Labeling-Package Insert		Label is not available on this site.
09/01/2022	SUPPL-45	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/22/2014	SUPPL-34	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/22/2014	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
09/22/2014	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
09/26/2006	SUPPL-21	Labeling		Label is not available on this site.
07/31/2006	SUPPL-20	Labeling		Label is not available on this site.
06/02/2005	SUPPL-11	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.

Therapeutic Equivalents for ANDA 065064

AMOXICILLIN AND CLAVULANATE POTASSIUM

TABLET;ORAL; 500MG;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	500MG;EQ 125MG BASE	TABLET;ORAL	Prescription	No	AB	091569	AUROBINDO PHARMA LTD
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET;ORAL	Prescription	No	AB	209992	DEVA HOLDING AS
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET;ORAL	Prescription	No	AB	205707	MICRO LABS LTD INDIA
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET;ORAL	Prescription	No	AB	065064	SANDOZ
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET;ORAL	Prescription	No	AB	065117	SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET;ORAL	Prescription	No	AB	065101	TEVA