Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050720
Company: US ANTIBIOTICS
Company: US ANTIBIOTICS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AUGMENTIN '875' | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 02/13/1996 | 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-33 | 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-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/2013 | SUPPL-28 | 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-26 | 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-25 | 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 | |
| 04/07/2008 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050720s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050720s024ltr.pdf | |
| 12/04/2008 | SUPPL-23 | 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-22 | 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-21 | 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-19 | 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-18 | 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-17 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s017_Augmentin.cfm |
| 12/04/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s016_Augmentin.cfm |
| 07/25/2003 | SUPPL-15 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50564slr043,50720slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050720s015_Augmentin.cfm |
| 05/01/2002 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s013_Augmentin.cfm |
| 04/17/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050720s012_Augmentin.cfm |
| 05/03/2001 | SUPPL-11 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050720s011_Augmentin.cfm |
| 11/19/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050720s009_Augmentin.cfm |
| 09/23/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050720s008_Augmentin.cfm |
| 02/01/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050720s007_Augmentin.cfm |
| 04/10/2002 | SUPPL-6 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s006_Augmentin.cfm |
| 02/11/1998 | SUPPL-5 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050720s005_Augmentin.cfm |
| 10/20/1997 | SUPPL-4 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050720s004_Augmentin.cfm |
| 02/11/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/19/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/15/1996 | SUPPL-1 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050720s001_Augmentin.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/25/2022 | SUPPL-33 | 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-28 | 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-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf | |
| 09/29/2011 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050564s052,050720s025lbl.pdf | |
| 12/04/2008 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s050lbl.pdf | |
| 06/09/2008 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s049,050720s022lbl.pdf | |
| 04/07/2008 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050720s024lbl.pdf |
AUGMENTIN '875'
TABLET;ORAL; 875MG;EQ 125MG 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 | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 091568 | AUROBINDO PHARMA LTD |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 209991 | DEVA HOLDING AS |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 203824 | HIKMA PHARMS |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 204755 | MICRO LABS LTD INDIA |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065063 | SANDOZ |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065093 | SANDOZ INC |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065096 | TEVA PHARMS USA |
| AUGMENTIN '875' | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | Yes | AB | 050720 | US ANTIBIOTICS |