Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065117
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE 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
11/27/2002 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065117.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2014 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

05/20/2010 SUPPL-13 Labeling-Container/Carton Labels

Label is not available on this site.

09/29/2009 SUPPL-12 Labeling

Label is not available on this site.

07/31/2006 SUPPL-6 Labeling

Label is not available on this site.

09/01/2005 SUPPL-5 Labeling

Label is not available on this site.

03/26/2004 SUPPL-2 Labeling

Label is not available on this site.

AMOXICILLIN AND CLAVULANATE POTASSIUM

TABLET;ORAL; 500MG;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 500MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 091569 AUROBINDO PHARMA LTD
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 205707 MICRO LABS LTD INDIA
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065064 SANDOZ
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065117 SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065101 TEVA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English