Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050564
Company: US ANTIBIOTICS
Company: US ANTIBIOTICS
| 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CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050564s060,050575s051,050597s052,050720s037,050725s036,050726s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050564Orig1s060, 050575Orig1s051, 050597Orig1s052, 050720Orig1s037, 050725Orig1s036, 050726Orig1s027ltr.pdf | |
| 08/25/2022 | SUPPL-59 | 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-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/2013 | SUPPL-55 | 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-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 |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050564s060,050575s051,050597s052,050720s037,050725s036,050726s027lbl.pdf | |
| 08/25/2022 | SUPPL-59 | 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-55 | 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-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 |