Permitil

NDA 12034, held by Schering. Fluphenazine Hydrochloride.

As of Nov 15, 2026, NDA 12034 (Permitil), held by Schering, was first approved by FDA on Sep 9, 1959, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 9, 1959
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Sep 9, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms


Permitil0.25MG · tablet;oral	Fluphenazine Hydrochloride	Discontinued
Permitil2.5MG · tablet;oral	Fluphenazine Hydrochloride	Discontinued
Permitil5MG · tablet;oral	Fluphenazine Hydrochloride	Discontinued
Permitil10MG · tablet;oral	Fluphenazine Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Nov 12, 2002	Supplement 11Labeling	Approved	None posted
Nov 12, 2002	Supplement 10Labeling	Approved	None posted
Nov 12, 2002	Supplement 9Labeling	Approved	None posted
Nov 12, 2002	Supplement 7Labeling	Approved	None posted
Nov 12, 2002	Supplement 4Labeling	Approved	None posted
May 19, 2000	Supplement 15Labeling	Approved	None posted
Oct 18, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 9, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 12034
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