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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050785
Company: US ANTIBIOTICS

Products on NDA 050785

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AUGMENTIN XR	AMOXICILLIN; CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050785

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50785lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50785ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50785_AugmentinXR.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2024	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050785s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050785Orig1s018ltr.pdf
11/02/2022	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050785Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050785Orig1s017ltr.pdf
09/30/2014	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/04/2014	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050785s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050785s015ltr.pdf
11/27/2013	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050785s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050785Orig1s014ltr.pdf
08/27/2010	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050785s011,s012ltr.pdf
08/27/2010	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf
08/26/2011	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050785s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785s009ltr.pdf
04/17/2008	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050785s008ltr.pdf
12/10/2008	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050785s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050785s007ltr.pdf
06/15/2005	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050785s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050785s006ltr.pdf
09/16/2004	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50785s005ltr.pdf
05/24/2004	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50785slr004ltr.pdf
05/30/2003	SUPPL-3	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50785scs003ltr.pdf
05/20/2003	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50785slr002ltr.pdf

Labels for NDA 050785

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2024	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050785s018lbl.pdf
11/02/2022	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050785Orig1s017lbl.pdf
11/02/2022	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050785Orig1s017lbl.pdf
04/04/2014	SUPPL-15	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050785s015lbl.pdf
11/27/2013	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050785s014lbl.pdf
08/26/2011	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050785s009lbl.pdf
08/27/2010	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf
08/27/2010	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf
12/10/2008	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050785s007lbl.pdf
06/15/2005	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050785s006lbl.pdf
09/25/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50785lbl.pdf

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