Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050725
Company: DR REDDYS LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AUGMENTIN '200' AMOXICILLIN; CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None Yes No
AUGMENTIN '400' AMOXICILLIN; CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None 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
05/31/1996 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
04/17/2015 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/30/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/22/2013 SUPPL-30 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-28 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-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050575s039,050597s046,050725s027,050726s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf
03/27/2008 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf
12/04/2008 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037, 050597s044, 050725025, 050726s019ltr.pdf
08/11/2004 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50725s024,50726s018ltr.pdf
06/03/2004 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf
12/23/2003 SUPPL-22 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050725_S023_Augmentin_APPROVAL_PACKAGE.pdf
06/13/2003 SUPPL-21 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050725_S021_Augmentin_APPROVAL_PACKAGE.pdf
10/17/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/2002 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/04/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/2003 SUPPL-17 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050725_S017_Augmentin_APPROVAL_PACKAGE.pdf
11/27/2002 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/07/2001 SUPPL-14 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050725_S014_Augmentin_APPROVAL_PACKAGE.pdf
04/17/2001 SUPPL-13 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050725_S013_Augmentin_APPROVAL_PACKAGE.pdf
03/07/2001 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/27/2000 SUPPL-11 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/050725_S011_Augmentin_APPROVAL_PACKAGE.pdf
05/03/2001 SUPPL-10 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050725_S010_Augmentin_APPROVAL_PACKAGE.pdf
06/08/2000 SUPPL-8 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/050725_S008_Augmentin_APPROVAL_PACKAGE.pdf
11/19/1999 SUPPL-7 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050725_S007_Augmentin_APPROVAL_PACKAGE.pdf
09/23/1999 SUPPL-6 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050725_S006_Augmentin_APPROVAL_PACKAGE.pdf
02/01/1999 SUPPL-5 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050725_S005_Augmentin_APPROVAL_PACKAGE.pdf
04/10/2002 SUPPL-4 Labeling Letter (PDF)
Review (PDF)

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/2002/050725_S004_Augmentin_APPROVAL PACKAGE.pdf
02/19/1998 SUPPL-3 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050725_S003_Augmentin_APPROVAL PACKAGE.pdf
02/11/1998 SUPPL-2 Labeling

Label is not available on this site.

03/19/1997 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/22/2013 SUPPL-30 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-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf
09/29/2011 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050575s039,050597s046,050725s027,050726s021lbl.pdf
12/04/2008 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf
03/27/2008 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf

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