Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065065
Company: SANDOZ

Products on ANDA 065065

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE;ORAL	Discontinued	None	No	No
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065065

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/18/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65065ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/2014	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
09/22/2014	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
09/22/2014	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
06/28/2011	SUPPL-25	Labeling		Label is not available on this site.
05/29/2009	SUPPL-22	Labeling		Label is not available on this site.
01/31/2008	SUPPL-19	Labeling		Label is not available on this site.
01/03/2007	SUPPL-18	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.