ANDA 213984, held by Zydus. Cariprazine Hydrochloride.
As of Nov 15, 2026, ANDA 213984 (Cariprazine Hydrochloride), held by Zydus, was first approved by FDA on Sep 9, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 9, 2022 | Original application | Approved |
| Cariprazine HydrochlorideEQ 1.5MG BASE · capsule;oral | Cariprazine Hydrochloride | Discontinued |
| Cariprazine HydrochlorideEQ 3MG BASE · capsule;oral | Cariprazine Hydrochloride | Discontinued |
| Cariprazine HydrochlorideEQ 4.5MG BASE · capsule;oral | Cariprazine Hydrochloride | Discontinued |
| Cariprazine HydrochlorideEQ 6MG BASE · capsule;oral | Cariprazine Hydrochloride | Discontinued |
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
