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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065162
Company: TEVA

Products on ANDA 065162

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065162

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/2004	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065162_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2024	SUPPL-40	Labeling, Labeling-Package Insert		Label is not available on this site.
04/26/2024	SUPPL-36	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/26/2024	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
04/26/2024	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
04/26/2013	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
03/05/2009	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065162s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065162s021ltr.pdf
09/08/2006	SUPPL-16	Labeling		Label is not available on this site.
10/17/2005	SUPPL-13	Labeling		Label is not available on this site.
02/17/2015	SUPPL-8	Labeling		Label is not available on this site.

Labels for ANDA 065162

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2009	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065162s021lbl.pdf

Therapeutic Equivalents for ANDA 065162

AMOXICILLIN AND CLAVULANATE POTASSIUM

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	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
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065420	WOCKHARDT BIO AG
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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