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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216877
Company: NEXUS

Products on ANDA 216877

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRANEXAMIC ACID	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216877

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216877

TRANEXAMIC ACID

SOLUTION;INTRAVENOUS; 1GM/100ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRANEXAMIC ACID	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217155	AMNEAL
TRANEXAMIC ACID	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	212020	EXELA PHARMA
TRANEXAMIC ACID	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218599	GLAND PHARMA LTD
TRANEXAMIC ACID	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216877	NEXUS

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