An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065056
Company: TEVA

Products on ANDA 065056

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065056

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2000	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/065056_amoxicillin_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2024	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
01/03/2024	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
10/22/2014	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
05/02/2013	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065056s017lbl.pdf
02/25/2009	SUPPL-14	Labeling		Label is not available on this site.
08/20/2002	SUPPL-6	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
08/20/2002	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
06/28/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/24/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/2001	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 065056

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/02/2013	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065056s017lbl.pdf

Therapeutic Equivalents for ANDA 065056

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

Top