Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050785
Company: DR REDDYS LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AUGMENTIN XR AMOXICILLIN; CLAVULANATE POTASSIUM 1GM;EQ 62.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes 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
09/25/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50785lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50785ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50785_AugmentinXR.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/04/2014 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050785s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050785s015ltr.pdf
11/27/2013 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050785s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050785Orig1s014ltr.pdf
08/27/2010 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050785s011,s012ltr.pdf
08/27/2010 SUPPL-11 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf
08/26/2011 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050785s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785s009ltr.pdf
04/17/2008 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050785s008ltr.pdf
12/10/2008 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050785s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050785s007ltr.pdf
06/15/2005 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050785s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050785s006ltr.pdf
09/16/2004 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50785s005ltr.pdf
05/24/2004 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50785slr004ltr.pdf
05/30/2003 SUPPL-3 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50785scs003ltr.pdf
05/20/2003 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50785slr002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/04/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050785s015lbl.pdf
11/27/2013 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050785s014lbl.pdf
08/26/2011 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050785s009lbl.pdf
08/27/2010 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf
08/27/2010 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf
12/10/2008 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050785s007lbl.pdf
06/15/2005 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050785s006lbl.pdf
09/25/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50785lbl.pdf

AUGMENTIN XR

TABLET, EXTENDED RELEASE;ORAL; 1GM;EQ 62.5MG 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 1GM;EQ 62.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090227 SANDOZ
AUGMENTIN XR AMOXICILLIN; CLAVULANATE POTASSIUM 1GM;EQ 62.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 050785 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