An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213315
Company: UNICHEM

Products on ANDA 213315

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213315

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213315

PRASUGREL HYDROCHLORIDE

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

Top