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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205133
Company: AUROBINDO PHARMA USA

Products on ANDA 205133

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 205133

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/2015	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 205133

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

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