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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022430
Company: AMRING PHARMS

Summary Review

Products on NDA 022430

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LYSTEDA	TRANEXAMIC ACID	650MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022430

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/13/2009	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022430lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022430s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022430_lysteda_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022430s000sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/07/2020	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022430s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022430Orig1s009ltr.pdf
05/23/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/23/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/03/2013	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022430Orig1s004ltr.pdf
08/21/2013	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022430Orig1s003ltr.pdf
04/06/2011	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022430s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022430s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/022430Orig1s002.pdf

Labels for NDA 022430

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/07/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022430s009lbl.pdf
10/03/2013	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s004lbl.pdf
08/21/2013	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s003lbl.pdf
04/06/2011	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022430s002lbl.pdf
11/13/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022430lbl.pdf

Therapeutic Equivalents for NDA 022430

LYSTEDA

TABLET;ORAL; 650MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LYSTEDA	TRANEXAMIC ACID	650MG	TABLET;ORAL	Prescription	Yes	AB	022430	AMRING PHARMS
TRANEXAMIC ACID	TRANEXAMIC ACID	650MG	TABLET;ORAL	Prescription	No	AB	202093	ACTAVIS LABS FL INC
TRANEXAMIC ACID	TRANEXAMIC ACID	650MG	TABLET;ORAL	Prescription	No	AB	203256	ANI PHARMS
TRANEXAMIC ACID	TRANEXAMIC ACID	650MG	TABLET;ORAL	Prescription	No	AB	205133	AUROBINDO PHARMA USA

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