ANDA 213932, held by Sun Pharm. Cariprazine Hydrochloride.
As of Nov 15, 2026, ANDA 213932 (Cariprazine Hydrochloride), held by Sun Pharm, was first approved by FDA on Sep 30, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 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
