Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050755
Company: US ANTIBIOTICS
Company: US ANTIBIOTICS
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 | Prescription | AB | 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 |
---|---|---|---|---|---|
05/01/2024 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050755s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050755Orig1s029ltr.pdf | |
09/22/2022 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050755s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050755Orig1s025ltr.pdf | |
06/30/2022 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050755Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050755Orig1s024ltr.pdf | |
03/16/2015 | SUPPL-22 | 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/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 |
---|---|---|---|---|---|
05/01/2024 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050755s029lbl.pdf | |
09/22/2022 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050755s025lbl.pdf | |
06/30/2022 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050755Orig1s024lbl.pdf | |
03/16/2015 | SUPPL-22 | 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/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 |
AUGMENTIN ES-600
FOR SUSPENSION;ORAL; 600MG/5ML;EQ 42.9MG 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 | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 201091 | AUROBINDO PHARMA LTD |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 209351 | DEVA HOLDING AS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065373 | HIKMA PHARMS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217805 | MICRO LABS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065358 | SANDOZ INC |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065162 | TEVA |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065420 | WOCKHARDT BIO AG |
AUGMENTIN ES-600 | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 050755 | US ANTIBIOTICS |