Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202093
Company: ACTAVIS LABS FL INC

Products on ANDA 202093

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRANEXAMIC ACID	TRANEXAMIC ACID	650MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202093

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/2012	ORIG-1	Approval	Not Applicable		Letter (PDF) Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202093s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202093Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202093Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2021	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/20/2015	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202093

TRANEXAMIC ACID

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