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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050813
Company: PRAGMA

Summary Review

Products on NDA 050813

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOXATAG	AMOXICILLIN	775MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050813

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050813lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050813s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050813_moxatag_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050813s000sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2022	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050813s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050813Orig1s009ltr.pdf
11/06/2019	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050813s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050813Orig1s008ltr.pdf
06/09/2015	SUPPL-3	Labeling-Package Insert, 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/2015/050813s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050813Orig1s003ltr.pdf

Labels for NDA 050813

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2022	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050813s009lbl.pdf
11/06/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050813s008lbl.pdf
06/09/2015	SUPPL-3	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/2015/050813s003lbl.pdf
06/09/2015	SUPPL-3	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/2015/050813s003lbl.pdf
01/23/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050813lbl.pdf

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