Prasugrel

Reduces thrombotic cardiovascular events (including stent thrombosis). ANDA 205927, held by Mylan. Prasugrel Hydrochloride.

As of Nov 15, 2026, ANDA 205927 (Prasugrel), held by Mylan, was first approved by FDA on Jul 12, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 12, 2017
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Prasugrel tablets are a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows:

Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI).
Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 12, 2017	Original application	Approved	Label Letter

Products

2 strengths and forms


PrasugrelEQ 5MG BASE · tablet;oral	Prasugrel Hydrochloride	Rx
PrasugrelEQ 10MG BASE · tablet;oral	Prasugrel Hydrochloride	Rx

All 3 submissions, including labeling and manufacturing supplements


May 29, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Jun 24, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jul 12, 2017	Original application	Approved	Label Letter

Identifiers

Application: ANDA 205927
Drugs@FDA: Overview at FDA
Company: Mylan

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters