Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050755
Company: DR REDDYS LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AUGMENTIN ES-600 AMOXICILLIN; CLAVULANATE POTASSIUM 600MG/5ML;EQ 42.9MG 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
06/22/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50755_Augmentin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50755ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50755_Augmentin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/16/2015 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050755s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050755Orig1s022ltr.pdf
09/30/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/08/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/26/2011 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050755s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785s009ltr.pdf
08/26/2011 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050755s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785s009ltr.pdf
04/17/2008 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050755s015ltr.pdf
01/16/2009 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050755s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050755s014ltr.pdf
12/17/2004 SUPPL-12 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50755s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755s012ltr.pdf
11/10/2004 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755s011ltr.pdf
06/03/2004 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50-755010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755slr010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050755_S010.pdf
10/17/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/2003 SUPPL-3 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50755slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/50-755s003_AugmentinTOC.cfm
11/27/2002 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/16/2015 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050755s022lbl.pdf
08/26/2011 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050755s016s018lbl.pdf
08/26/2011 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050755s016s018lbl.pdf
01/16/2009 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050755s014lbl.pdf
12/17/2004 SUPPL-12 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50755s012lbl.pdf
06/03/2004 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50-755010lbl.pdf
06/22/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50755_Augmentin_prntlbl.pdf

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