Reduces thrombotic cardiovascular events (including stent thrombosis). ANDA 205897, held by Panacea. Prasugrel Hydrochloride.
As of Nov 15, 2026, ANDA 205897 (Prasugrel), held by Panacea, was first approved by FDA on Oct 16, 2017, with 2 approved supplements and 0 published complete response letters.
Prasugrel tablets is 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2017 | Original application | Approved |
| PrasugrelEQ 5MG BASE · tablet;oral | Prasugrel Hydrochloride | Rx |
| PrasugrelEQ 10MG BASE · tablet;oral | Prasugrel Hydrochloride | Rx |
| Apr 25, 2025 | Supplement 8Labeling · Standard review | Approved | None posted |
| Apr 17, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 16, 2017 | Original application | Approved |
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
