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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050720
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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/17/2026 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050720s039lbl.pdf
05/01/2024 SUPPL-37 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-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
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