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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065189
Company: SANDOZ

Products on ANDA 065189

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065189

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/23/2005	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/065189_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-30	Labeling-Package Insert		Label is not available on this site.
04/29/2024	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
09/22/2014	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/22/2014	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
09/22/2014	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/26/2006	SUPPL-6	Labeling		Label is not available on this site.
07/31/2006	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065189

AMOXICILLIN AND CLAVULANATE POTASSIUM

TABLET;ORAL; 250MG;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	250MG;EQ 125MG BASE	TABLET;ORAL	Prescription	No	AB	091569	AUROBINDO PHARMA LTD
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET;ORAL	Prescription	No	AB	205707	MICRO LABS LTD INDIA
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET;ORAL	Prescription	No	AB	065189	SANDOZ

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