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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022307
Company: COSETTE

Medication Guide

Priority 3 Approval Package

Other Important Information from FDA

Summary Review

Products on NDA 022307

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EFFIENT	PRASUGREL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
EFFIENT	PRASUGREL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022307

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2009	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022307s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022307s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022307s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022307s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2020	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022307s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022307Orig1s018ltr.pdf
03/28/2019	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022307s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022307Orig1s016ltr.pdf
03/09/2018	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022307s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022307Orig1s015ltr.pdf
07/12/2016	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022307Orig1s014ltr.pdf
01/14/2016	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022307Orig1s013ltr.pdf
07/07/2015	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022307s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022307Orig1s012ltr.pdf
11/19/2013	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022307s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022307Orig1s010ltr.pdf
10/16/2013	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022307s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022307Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022307Orig1s008TOC.cfm
11/30/2012	SUPPL-7	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022307s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022307Orig1s007ltr.pdf
03/23/2012	SUPPL-6	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022307s006ltr.pdf
09/27/2011	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022307s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022307s003ltr.pdf
12/06/2010	SUPPL-2	Labeling, REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022307s002ltr.pdf
04/16/2010	SUPPL-1	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022307s001ltr.pdf

Labels for NDA 022307

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2020	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022307s018lbl.pdf
12/22/2020	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022307s018lbl.pdf
03/28/2019	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022307s016lbl.pdf
03/28/2019	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022307s016lbl.pdf
03/28/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022307s016lbl.pdf
03/09/2018	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022307s015lbl.pdf
07/12/2016	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s014lbl.pdf
01/14/2016	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s013lbl.pdf
07/07/2015	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022307s012lbl.pdf
11/19/2013	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022307s010lbl.pdf
10/16/2013	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022307s008lbl.pdf
11/30/2012	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022307s007lbl.pdf
09/27/2011	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022307s003lbl.pdf
12/06/2010	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s002lbl.pdf
12/06/2010	SUPPL-2	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s002lbl.pdf
04/16/2010	SUPPL-1	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s001lbl.pdf
07/10/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022307s000lbl.pdf

Therapeutic Equivalents for NDA 022307

EFFIENT

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EFFIENT	PRASUGREL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	Yes	AB	022307	COSETTE
PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	205987	ACCORD HLTHCARE
PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	205913	AMNEAL PHARMS
PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	205888	AUROBINDO PHARMA
PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	206021	HEC PHARM
PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	205927	MYLAN
PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	205897	PANACEA
PRASUGREL HYDROCHLORIDE	PRASUGREL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	213315	UNICHEM

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EFFIENT	PRASUGREL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	Yes	AB	022307	COSETTE
PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	205987	ACCORD HLTHCARE
PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	205913	AMNEAL PHARMS
PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	205888	AUROBINDO PHARMA
PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	206021	HEC PHARM
PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	205927	MYLAN
PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	205897	PANACEA
PRASUGREL HYDROCHLORIDE	PRASUGREL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	213315	UNICHEM

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