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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020913
Company: MEDICURE

Products on NDA 020913

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AGGRASTAT	TIROFIBAN HYDROCHLORIDE	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	No	No
AGGRASTAT	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	No
AGGRASTAT	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020913

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/1998	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20913lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20913ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20913.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2020	SUPPL-28		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020913Orig1s028ReplacementLbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020913Orig1s028Replacementltr.pdf
05/16/2019	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020912s027,020913s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020912Orig1s027,%20020913Orig1s026ltr.pdf
09/07/2016	SUPPL-22	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020912s024,020913s022lbl.pdf
06/16/2016	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/21/2015	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020912s021,020913s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020912Orig1s021,020913Orig1s018ltr.pdf
06/06/2012	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020912s018,020913s017ltr.pdf
03/05/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
05/17/2002	SUPPL-10	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s010ltr.pdf
06/17/2002	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s009ltr.pdf
07/24/2002	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913slr008and20912slr009ltr.pdf
09/25/2001	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-913S007_Aggrastat.pdf
03/23/2001	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20913s6ltr.pdf
04/20/2000	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/11/2000	SUPPL-4	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20912-s004_aggrasat.pdf
06/09/1999	SUPPL-2	Labeling		Label is not available on this site.
07/09/1999	SUPPL-1	Labeling	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_Aggrastat.cfm

Labels for NDA 020913

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2020	SUPPL-28	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020913Orig1s028ReplacementLbl.pdf
05/16/2019	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020912s027,020913s026lbl.pdf
09/07/2016	SUPPL-22	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020912s024,020913s022lbl.pdf
04/21/2015	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020912s021,020913s018lbl.pdf
06/06/2012	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.pdf
07/09/1999	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_prntlbl.pdf
05/14/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20913lbl.pdf

Therapeutic Equivalents for NDA 020913

AGGRASTAT

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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