Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050564
Company: DR REDDYS LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
AUGMENTIN '500' AMOXICILLIN; CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
08/06/1984 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY

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-57 Manufacturing (CMC)

Label is not available on this site.

01/22/2013 SUPPL-55 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-53 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-52 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
03/26/2008 SUPPL-51 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s051ltr.pdf
12/04/2008 SUPPL-50 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-49 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-48 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-47 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-46 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-45 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2002 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/2003 SUPPL-43 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50564slr043,50720slr015ltr.pdf
05/01/2002 SUPPL-41 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/17/2001 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/2001 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/19/1999 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1999 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1999 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/2002 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf
02/12/1998 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/11/1998 SUPPL-32 Labeling

Label is not available on this site.

03/19/1997 SUPPL-31 Labeling

Label is not available on this site.

03/04/1996 SUPPL-26 Labeling

Label is not available on this site.

07/06/1994 SUPPL-25 Labeling

Label is not available on this site.

06/21/1994 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/15/1994 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1996 SUPPL-22 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050564s022_augmentin.pdf
07/21/1992 SUPPL-21 Labeling

Label is not available on this site.

05/21/1992 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/22/1992 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1991 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1992 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1991 SUPPL-16 Labeling

Label is not available on this site.

05/22/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/09/1989 SUPPL-12 Labeling

Label is not available on this site.

02/07/1989 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/29/1988 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/05/1988 SUPPL-9 Labeling

Label is not available on this site.

02/10/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/27/1987 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/29/1987 SUPPL-6 Labeling

Label is not available on this site.

12/21/1985 SUPPL-4 Labeling

Label is not available on this site.

11/25/1985 SUPPL-3 Labeling

Label is not available on this site.

11/21/1986 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-55 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-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf
09/29/2011 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050564s052,050720s025lbl.pdf
12/04/2008 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s050lbl.pdf
06/09/2008 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s049,050720s022lbl.pdf
03/26/2008 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s051lbl.pdf

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