Prasugrel

ANDA 205790, held by Chartwell Rx. Prasugrel Hydrochloride.

As of Nov 15, 2026, ANDA 205790 (Prasugrel), held by Chartwell Rx, was first approved by FDA on Oct 16, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 16, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 16, 2017	Original application	Approved	Letter

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Feb 16, 2022	Supplement 3Labeling · Standard review	Approved	None posted
Nov 4, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Nov 4, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Oct 16, 2017	Original application	Approved	Letter

Identifiers

Application: ANDA 205790
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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