Abstral

NDA 22510, held by Sentynl Theraps Inc. Fentanyl Citrate.

As of Nov 15, 2026, NDA 22510 (Abstral), held by Sentynl Theraps Inc, was first approved by FDA on Jan 7, 2011, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 7, 2011
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jan 7, 2011	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Other Letter

Products

6 strengths and forms


AbstralEQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;sublingual	Fentanyl Citrate	DiscontinuedReference drug
AbstralEQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;sublingual	Fentanyl Citrate	DiscontinuedReference drug
AbstralEQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;sublingual	Fentanyl Citrate	DiscontinuedReference drug
AbstralEQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;sublingual	Fentanyl Citrate	DiscontinuedReference drug
AbstralEQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;sublingual	Fentanyl Citrate	DiscontinuedReference drug
AbstralEQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;sublingual	Fentanyl Citrate	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Oct 7, 2019	Supplement 18Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 7, 2017	Supplement 17REMS	Approved	Letter
Dec 16, 2016	Supplement 15Labeling · Standard review	Approved	Label Letter
Dec 24, 2014	Supplement 14REMS	Approved	Letter
Nov 4, 2014	Supplement 13Labeling · Standard review	Approved	Letter Label
Nov 7, 2013	Supplement 7REMS	Approved	Letter
Oct 2, 2013	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 26, 2013	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 5, 2012	Supplement 5REMS	Approved	Label Letter
Dec 28, 2011	Supplement 3REMS	Approved	Label Letter
Jan 7, 2011	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Other Letter

Identifiers

Application: NDA 22510
Drugs@FDA: Overview at FDA
Company: Sentynl Therapeutics

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