Fentanyl

NDA 20195, held by Cephalon. Fentanyl Citrate.

As of Nov 14, 2026, NDA 20195 (Fentanyl), held by Cephalon, was first approved by FDA on Oct 4, 1993, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 4, 1993
Review: Priority
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below


May 20, 1996	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review
Oct 30, 1995	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 4, 1993	Original applicationNew dosage form · Priority review	Approved	None posted

Products

4 strengths and forms


FentanylEQ 0.2MG BASE · troche/lozenge;oral	Fentanyl Citrate	Discontinued
FentanylEQ 0.3MG BASE · troche/lozenge;oral	Fentanyl Citrate	Discontinued
FentanylEQ 0.4MG BASE · troche/lozenge;oral	Fentanyl Citrate	Discontinued
FentanylEQ 0.1MG BASE · troche/lozenge;oral	Fentanyl Citrate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Sep 1, 2000	Supplement 5Manufacturing · Priority review	Approved	None posted
Aug 25, 2000	Supplement 4Manufacturing · Priority review	Approved	None posted
May 20, 1996	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review
Oct 30, 1995	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 4, 1993	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20195
Drugs@FDA: Overview at FDA
Company: Cephalon

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