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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216379
Company: EUGIA PHARMA

Products on ANDA 216379

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216379

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216379

TIROFIBAN HYDROCHLORIDE

SOLUTION;INTRAVENOUS; EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AGGRASTAT	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	020913	MEDICURE
TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216379	EUGIA PHARMA
TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213947	NEXUS

SOLUTION;INTRAVENOUS; EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AGGRASTAT	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	020913	MEDICURE
TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216379	EUGIA PHARMA
TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	206888	GLAND PHARMA LTD
TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213947	NEXUS

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