Drugs@FDA: FDA Approved Drug Products

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

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

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

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