Trilafon

NDA 11557, held by Schering. Perphenazine.

As of Nov 14, 2026, NDA 11557 (Trilafon), held by Schering, was first approved by FDA on Dec 12, 1958, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 12, 1958
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Dec 12, 1958	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Trilafon16MG/5ML · concentrate;oral	Perphenazine	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Sep 17, 2001	Supplement 24Labeling · Standard review	Approved	None posted
Sep 17, 2001	Supplement 17Labeling	Approved	None posted
Sep 17, 2001	Supplement 14Labeling	Approved	None posted
Sep 17, 2001	Supplement 13Labeling	Approved	None posted
Sep 17, 2001	Supplement 9Labeling	Approved	None posted
Sep 17, 2001	Supplement 8Labeling	Approved	None posted
Sep 17, 2001	Supplement 7Labeling	Approved	None posted
Sep 17, 2001	Supplement 6Labeling	Approved	None posted
Sep 17, 2001	Supplement 5Labeling	Approved	None posted
Sep 17, 2001	Supplement 4Labeling	Approved	None posted
Sep 17, 2001	Supplement 3Labeling	Approved	None posted
Mar 29, 1982	Supplement 10Labeling	Approved	None posted
Dec 12, 1958	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11557
Drugs@FDA: Overview at FDA
Company: Schering Corporation

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