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CLAVULANATE POTASSIUM | 125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |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CLAVULANATE POTASSIUM | 250MG;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/17/2026 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050597s053lbl.pdf | |
| 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 |