Trilafon

NDA 10775, held by Schering. Perphenazine.

As of Nov 14, 2026, NDA 10775 (Trilafon), held by Schering, was first approved by FDA on Feb 27, 1957, with 9 approved supplements and 0 published complete response letters.

First approved: Feb 27, 1957
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Feb 27, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms


Trilafon2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Perphenazine	DiscontinuedReference drug
Trilafon4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Perphenazine	DiscontinuedReference drug
Trilafon8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Perphenazine	DiscontinuedReference drug
Trilafon16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Perphenazine	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements


May 10, 2002	Supplement 31Labeling · Standard review	Approved	Review Letter Label
Oct 18, 2001	Supplement 30Labeling · Standard review	Approved	None posted
Mar 15, 2001	Supplement 29Labeling · Standard review	Approved	Review Letter
Jun 1, 2000	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 3, 2000	Supplement 28Manufacturing · Standard review	Approved	None posted
Apr 7, 1999	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 21, 1998	Supplement 25Manufacturing · Standard review	Approved	None posted
Oct 20, 1995	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 29, 1982	Supplement 15Labeling · Standard review	Approved	None posted
Feb 27, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 10775
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