Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206888
Company: GLAND PHARMA LTD

Products on ANDA 206888

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 206888

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206888Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 206888

TIROFIBAN HYDROCHLORIDE

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