Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050597
Company: US ANTIBIOTICS
Company: US ANTIBIOTICS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AUGMENTIN '125' | AMOXICILLIN; CLAVULANATE POTASSIUM | 125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |
| AUGMENTIN '250' | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/22/1985 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050597Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-52 | 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-51 | 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 | |
| 01/22/2013 | SUPPL-49 | 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-47 | 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-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050597s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf | |
| 03/27/2008 | SUPPL-45 | 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-44 | 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-43 | 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-42 | 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-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/2002 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/2003 | SUPPL-39 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf |
| 03/28/2002 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/2001 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/2001 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/19/1999 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/23/1999 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1999 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/2002 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf |
| 02/19/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1998 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/19/1997 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/06/1994 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/21/1994 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/15/1994 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/21/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/04/1992 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/1991 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1992 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/05/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/22/1991 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/09/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/02/1989 | SUPPL-12 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 10/25/1991 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/1988 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/04/1989 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/27/1987 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/23/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1987 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/21/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/21/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/26/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/27/1985 | 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-52 | 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-51 | 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-49 | 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-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf | |
| 09/29/2011 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050597s046lbl.pdf | |
| 12/04/2008 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf | |
| 03/27/2008 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf |