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): 065119
Company: TEVA

Products on ANDA 065119

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No
AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065119

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/2002	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
01/03/2024	SUPPL-31	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/17/2020	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
11/20/2012	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065119s020lbl.pdf
11/26/2012	SUPPL-18	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/10/2011	SUPPL-15	Labeling		Label is not available on this site.

Labels for ANDA 065119

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/20/2012	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065119s020lbl.pdf

Therapeutic Equivalents for ANDA 065119

AMOXICILLIN

FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065334	AUROBINDO
AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065325	HIKMA
AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065378	SANDOZ
AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065119	TEVA

FOR SUSPENSION;ORAL; 400MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065334	AUROBINDO
AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065325	HIKMA
AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065378	SANDOZ
AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065119	TEVA
AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065319	WOCKHARDT BIO AG
AMOXIL	AMOXICILLIN	400MG/5ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	050760	US ANTIBIOTICS

Top