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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050575
Company: US ANTIBIOTICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AUGMENTIN '125' AMOXICILLIN; CLAVULANATE POTASSIUM 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION;ORAL Prescription AB Yes No
AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION;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
08/06/1984 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
08/25/2022 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050564Orig1s059,050575Orig1s048,050597Orig1s051,050720Orig1s033,050725Orig1s035,050726Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050564Orig1s059; 050575Orig1s048; 050597Orig1s051; 050720Orig1s033; 050725Orig1s035; 050726Orig1s026ltr.pdf
09/30/2014 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

01/22/2013 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. 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-40 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-39 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-38 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-37 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-36 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-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf
10/17/2002 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2002 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/2003 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf
04/17/2001 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1999 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1999 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1999 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/2002 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf
02/11/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/11/1998 SUPPL-23 Labeling

Label is not available on this site.

03/19/1997 SUPPL-22 Labeling

Label is not available on this site.

03/04/1996 SUPPL-19 Labeling

Label is not available on this site.

07/06/1994 SUPPL-18 Labeling

Label is not available on this site.

09/15/1994 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1996 SUPPL-16 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-15 Labeling

Label is not available on this site.

11/05/1991 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1994 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1991 SUPPL-12 Labeling

Label is not available on this site.

05/22/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/25/2022 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050564Orig1s059,050575Orig1s048,050597Orig1s051,050720Orig1s033,050725Orig1s035,050726Orig1s026lbl.pdf
01/22/2013 SUPPL-42 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf
01/22/2013 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf
09/29/2011 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050575s039,050597s046,050725s027,050726s021lbl.pdf
12/04/2008 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf
03/27/2008 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf

AUGMENTIN '125'

FOR SUSPENSION;ORAL; 125MG/5ML;EQ 31.25MG BASE/5ML
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 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 209371 AUROBINDO PHARMA
AUGMENTIN '125' AMOXICILLIN; CLAVULANATE POTASSIUM 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050575 US ANTIBIOTICS

AUGMENTIN '250'

FOR SUSPENSION;ORAL; 250MG/5ML;EQ 62.5MG BASE/5ML
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 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 209371 AUROBINDO PHARMA
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065431 WOCKHARDT BIO AG
AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050575 US ANTIBIOTICS
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