Reduces thrombotic cardiovascular events (including stent thrombosis). ANDA 213315, held by Unichem. Prasugrel Hydrochloride.
As of Nov 15, 2026, ANDA 213315 (Prasugrel Hydrochloride), held by Unichem, was first approved by FDA on Aug 28, 2023, with 0 approved supplements and 0 published complete response letters.
Prasugrel 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:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2023 | Original application | Approved | None posted |
| Prasugrel HydrochlorideEQ 5MG BASE · tablet;oral | Prasugrel Hydrochloride | Rx |
| Prasugrel HydrochlorideEQ 10MG BASE · tablet;oral | Prasugrel Hydrochloride | 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
