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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050755
Company: US ANTIBIOTICS

Products on NDA 050755

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AUGMENTIN ES-600	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050755

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2001	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50755_Augmentin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50755ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50755_Augmentin.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2024	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050755s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050755Orig1s031ltr.pdf
05/01/2024	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050755s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050755Orig1s029ltr.pdf
09/22/2022	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050755s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050755Orig1s025ltr.pdf
06/30/2022	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050755Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050755Orig1s024ltr.pdf
03/16/2015	SUPPL-22	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/2015/050755s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050755Orig1s022ltr.pdf
09/30/2014	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/08/2014	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
08/26/2011	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050755s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785s009ltr.pdf
08/26/2011	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050755s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785s009ltr.pdf
04/17/2008	SUPPL-15	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050755s015ltr.pdf
01/16/2009	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050755s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050755s014ltr.pdf
12/17/2004	SUPPL-12	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50755s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755s012ltr.pdf
11/10/2004	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755s011ltr.pdf
06/03/2004	SUPPL-10	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50-755010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755slr010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050755_S010.pdf
10/17/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/12/2003	SUPPL-3	Labeling	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50755slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/50-755s003_AugmentinTOC.html
11/27/2002	SUPPL-1	Manufacturing (CMC)-Formulation		Label is not available on this site.

Labels for NDA 050755

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2024	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050755s031lbl.pdf
05/01/2024	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050755s029lbl.pdf
09/22/2022	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050755s025lbl.pdf
06/30/2022	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050755Orig1s024lbl.pdf
03/16/2015	SUPPL-22	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/2015/050755s022lbl.pdf
08/26/2011	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050755s016s018lbl.pdf
08/26/2011	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050755s016s018lbl.pdf
01/16/2009	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050755s014lbl.pdf
12/17/2004	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50755s012lbl.pdf
06/03/2004	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50-755010lbl.pdf
06/22/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50755_Augmentin_prntlbl.pdf

Therapeutic Equivalents for NDA 050755

AUGMENTIN ES-600

FOR SUSPENSION;ORAL; 600MG/5ML;EQ 42.9MG BASE/5ML
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	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	201091	AUROBINDO PHARMA LTD
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065420	CIPLA
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	209351	DEVA HOLDING AS
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065373	HIKMA PHARMS
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	217805	MICRO LABS
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065358	SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065162	TEVA
AUGMENTIN ES-600	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	050755	US ANTIBIOTICS

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