Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065256
Company: AUROBINDO

Products on ANDA 065256

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXICILLIN	AMOXICILLIN	500MG	TABLET;ORAL	Prescription	AB	No	No
AMOXICILLIN	AMOXICILLIN	875MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065256

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2005	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/07/2024	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
09/18/2024	SUPPL-27	Labeling-Container/Carton Labels		Label is not available on this site.
05/01/2024	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
04/11/2024	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/11/2024	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
04/11/2024	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/11/2024	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
02/21/2013	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/31/2009	SUPPL-4	Labeling		Label is not available on this site.
10/28/2008	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065256

AMOXICILLIN

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMOXICILLIN	AMOXICILLIN	500MG	TABLET;ORAL	Prescription	No	AB	065256	AUROBINDO
AMOXICILLIN	AMOXICILLIN	500MG	TABLET;ORAL	Prescription	No	AB	065228	SANDOZ
AMOXICILLIN	AMOXICILLIN	500MG	TABLET;ORAL	Prescription	No	AB	065056	TEVA

TABLET;ORAL; 875MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMOXICILLIN	AMOXICILLIN	875MG	TABLET;ORAL	Prescription	No	AB	065256	AUROBINDO
AMOXICILLIN	AMOXICILLIN	875MG	TABLET;ORAL	Prescription	No	AB	065255	HIKMA
AMOXICILLIN	AMOXICILLIN	875MG	TABLET;ORAL	Prescription	No	AB	065228	SANDOZ
AMOXICILLIN	AMOXICILLIN	875MG	TABLET;ORAL	Prescription	No	AB	065056	TEVA