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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050542
Company: US ANTIBIOTICS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXIL AMOXICILLIN 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No
AMOXIL AMOXICILLIN 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No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
10/21/1980 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
05/01/2024 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050542Orig1s032, 050754Orig1s022, 050760Orig1s023, 050761Orig1s019ltr.pdf
11/02/2022 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050542Orig1s031,050754Orig1s021,050760Orig1s021,050761Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050542Orig1s031; 050754Orig1s021; 050760Orig1s021; 050761Orig1s018ltr.pdf
12/03/2015 SUPPL-30 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/2015/050542s030,050754s020,050760s020,050761s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf
09/24/2015 SUPPL-29 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Origs029,050754Orig1s019,050760Orig1s019,050761Orig1s016ltr.pdf
11/16/2011 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf
11/16/2011 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf
11/16/2011 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf
03/28/2008 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050760s11,050761s11,050754s12,050542s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011, 050761s011,050754s012, 050542s025ltr.pdf
06/09/2008 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760s10,050761s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024, 050754s011, 050760s010, 050761s010ltr.pdf
01/26/2006 SUPPL-23 Labeling

Label is not available on this site.
07/13/2004 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50760s008,50761s008rltr.pdf
12/18/2003 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr007,50754slr008,50761slr007ltr.pdf
12/04/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
05/12/2003 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr019,50754slr004,50760slr003,50761slr003ltr.pdf
04/17/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
05/16/2000 SUPPL-17 Labeling Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-542s017_50-754s002_50-760s001_50-761s001_Amoxil.cfm
04/10/2002 SUPPL-16 Labeling Letter (PDF)
Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50542s16ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-542s016_50-754s001_Amoxil.cfm
02/12/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
02/27/1998 SUPPL-11 Efficacy-New Indication Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050542s005s010s011.cfm
02/27/1998 SUPPL-10 Labeling Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050542s005s010s011.cfm
01/10/1995 SUPPL-8 Labeling

Label is not available on this site.
09/13/1993 SUPPL-7 Labeling

Label is not available on this site.
04/10/1991 SUPPL-6 Labeling

Label is not available on this site.
02/27/1998 SUPPL-5 Labeling Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050542s005s010s011.cfm
04/23/1991 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
02/08/1989 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.
09/12/1988 SUPPL-2 Labeling

Label is not available on this site.
12/17/1985 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-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf
11/02/2022 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050542Orig1s031,050754Orig1s021,050760Orig1s021,050761Orig1s018lbl.pdf
12/03/2015 SUPPL-30 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/2015/050542s030,050754s020,050760s020,050761s017lbl.pdf
09/24/2015 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf
09/24/2015 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf
11/16/2011 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf
11/16/2011 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf
11/16/2011 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf
06/09/2008 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760s10,050761s10lbl.pdf
03/28/2008 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050760s11,050761s11,050754s12,050542s25lbl.pdf
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