ANDA 213982, held by Aurobindo Pharma Ltd. Cariprazine Hydrochloride.
As of Nov 15, 2026, ANDA 213982 (Cariprazine Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Dec 16, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 2025 | Original application | Approved | None posted |
| Cariprazine HydrochlorideEQ 1.5MG BASE · capsule;oral | Cariprazine Hydrochloride | Discontinued |
| Cariprazine HydrochlorideEQ 3MG 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
