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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205927
Company: MYLAN

Products on ANDA 205927

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205927

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/2017	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205927Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205927Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2024	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/24/2020	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Labels for ANDA 205927

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/12/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205927Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 205927

PRASUGREL

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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