Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050720
Company: DR REDDYS LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AUGMENTIN '875' AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/13/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2014 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/28/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/22/2013 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf
01/22/2013 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf
09/29/2011 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050564s052,050720s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050564s052,050720s025ltr.pdf
04/07/2008 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050720s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050720s024ltr.pdf
12/04/2008 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s050, 050720s023ltr.pdf
06/09/2008 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s049,050720s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s049, 050720s022ltr.pdf
08/05/2005 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050564s048,050721s021ltr.pdf
08/30/2004 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50564s047,50720s019ltr.pdf
05/27/2004 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50564slr046,50720slr018ltr.pdf
10/17/2002 SUPPL-17 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s017_Augmentin.cfm
12/04/2002 SUPPL-16 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s016_Augmentin.cfm
07/25/2003 SUPPL-15 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50564slr043,50720slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050720s015_Augmentin.cfm
05/01/2002 SUPPL-13 Manufacturing (CMC)-Expiration Date Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s013_Augmentin.cfm
04/17/2001 SUPPL-12 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050720s012_Augmentin.cfm
05/03/2001 SUPPL-11 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050720s011_Augmentin.cfm
11/19/1999 SUPPL-9 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050720s009_Augmentin.cfm
09/23/1999 SUPPL-8 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050720s008_Augmentin.cfm
02/01/1999 SUPPL-7 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050720s007_Augmentin.cfm
04/10/2002 SUPPL-6 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s006_Augmentin.cfm
02/11/1998 SUPPL-5 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050720s005_Augmentin.cfm
10/20/1997 SUPPL-4 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050720s004_Augmentin.cfm
02/11/1998 SUPPL-3 Labeling

Label is not available on this site.

03/19/1997 SUPPL-2 Labeling

Label is not available on this site.

05/15/1996 SUPPL-1 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050720s001_Augmentin.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/22/2013 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf
01/22/2013 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf
09/29/2011 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050564s052,050720s025lbl.pdf
12/04/2008 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s050lbl.pdf
06/09/2008 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s049,050720s022lbl.pdf
04/07/2008 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050720s024lbl.pdf

AUGMENTIN '875'

TABLET;ORAL; 875MG;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 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 091568 AUROBINDO PHARMA LTD
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 203824 HIKMA PHARMS
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 204755 MICRO LABS LTD INDIA
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065063 SANDOZ
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065093 SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription No AB 065096 TEVA PHARMS USA
AUGMENTIN '875' AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET;ORAL Prescription Yes AB 050720 DR REDDYS LABS INC

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