Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203256
Company: ANI PHARMS

Products on ANDA 203256

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 203256

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/2016	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203256

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