Manages schizophrenia. ANDA 40209, held by Mylan. Trifluoperazine Hydrochloride.
As of Nov 15, 2026, ANDA 40209 (Trifluoperazine Hydrochloride), held by Mylan, was first approved by FDA on Jul 7, 1997, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For the management of schizophrenia. Trifluoperazine hydrochloride tablets, USP are effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine hydrochloride tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 7, 1997 | Original application | Approved | None posted |
| Trifluoperazine HydrochlorideEQ 1MG BASE · tablet;oral | Trifluoperazine Hydrochloride | Rx |
| Trifluoperazine HydrochlorideEQ 2MG BASE · tablet;oral | Trifluoperazine Hydrochloride | Rx |
| Trifluoperazine HydrochlorideEQ 5MG BASE · tablet;oral | Trifluoperazine Hydrochloride | Rx |
| Trifluoperazine HydrochlorideEQ 10MG BASE · tablet;oral | Trifluoperazine Hydrochloride | Rx |
| Jan 22, 2025 | Supplement 22Labeling · Standard review | Approved | None posted |
| Jan 14, 2025 | Supplement 21Labeling · Standard review | Approved | None posted |
| Dec 3, 2010 | Supplement 11Labeling | Approved | None posted |
| May 22, 2009 | Supplement 9Labeling | Approved | None posted |
| Sep 8, 2008 | Supplement 8Labeling | Approved | None posted |
| Aug 19, 2008 | Supplement 5Labeling | Approved | None posted |
| Jun 13, 2003 | Supplement 2Labeling | Approved | None posted |
| Jul 7, 1997 | Original application | Approved | None posted |
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
