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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050754
Company: US ANTIBIOTICS

Products on NDA 050754

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXIL	AMOXICILLIN	875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
AMOXIL	AMOXICILLIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050754

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50754AP.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50754.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2022	SUPPL-21	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-20	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-19	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/2015/050754s019ltr.pdf050542Origs029,050754Orig1s019,050760Orig1s019,050761Orig1s016ltr.pdf
09/30/2014	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
11/16/2011	SUPPL-17	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-14	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-13	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-12	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-11	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-10	Labeling		Label is not available on this site.
07/13/2004	SUPPL-9	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-8	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-7	Manufacturing (CMC)-Control		Label is not available on this site.
05/01/2002	SUPPL-6	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
04/25/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
05/12/2003	SUPPL-4	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-3	Manufacturing (CMC)-Control		Label is not available on this site.
05/16/2000	SUPPL-2	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-1	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

Labels for NDA 050754

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2022	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050542Orig1s031,050754Orig1s021,050760Orig1s021,050761Orig1s018lbl.pdf
12/03/2015	SUPPL-20	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-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf
09/24/2015	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf
11/16/2011	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf
11/16/2011	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf
11/16/2011	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf
06/09/2008	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760s10,050761s10lbl.pdf
03/28/2008	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050760s11,050761s11,050754s12,050542s25lbl.pdf

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