Fentanyl-25, Fentanyl-50, Fentanyl-75

ANDA 77051, held by Lavipharm Labs. Fentanyl.

As of Nov 14, 2026, ANDA 77051 (Fentanyl-25, Fentanyl-50, Fentanyl-75), held by Lavipharm Labs, was first approved by FDA on Aug 4, 2006, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 4, 2006
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Aug 4, 2006	Original application	Approved	None posted

Products

4 strengths and forms


Fentanyl-2525MCG/HR · film, extended release;transdermal	Fentanyl	Discontinued
Fentanyl-5050MCG/HR · film, extended release;transdermal	Fentanyl	Discontinued
Fentanyl-7575MCG/HR · film, extended release;transdermal	Fentanyl	Discontinued
Fentanyl-100100MCG/HR · film, extended release;transdermal	Fentanyl	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Dec 15, 2010	Supplement 5Labeling	Approved	None posted
Jan 9, 2008	Supplement 1Manufacturing	Approved	None posted
Aug 4, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77051
Drugs@FDA: Overview at FDA
Company: Lavipharm Labs

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