Alfenta

NDA 19353, held by Rising. Alfentanil Hydrochloride.

As of Nov 13, 2026, NDA 19353 (Alfenta), held by Rising, was first approved by FDA on Dec 29, 1986, with 20 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1986
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Nov 22, 1993	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 29, 1986	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
AlfentaEQ 0.5MG BASE/ML · injectable;injection	Alfentanil Hydrochloride	RxReference drug

All 22 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 22, 2025	Supplement 31Labeling · Standard review	Approved	Label Letter
Dec 15, 2023	Supplement 29Labeling · Standard review	Approved	Letter Label
Aug 8, 2022	Supplement 24Manufacturing	Tentative approval	Letter
Oct 7, 2019	Supplement 23Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 21Labeling · Standard review	Approved	Label Letter
Jul 24, 2015	Supplement 19Labeling · Standard review	Approved	Label Letter
May 25, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 20, 1998	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 28, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 30, 1995	Supplement 13Labeling · Standard review	Approved	None posted
Aug 3, 1995	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 22, 1995	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 18, 1994	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 7, 1994	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 7, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 22, 1993	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 10, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 7, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 6, 1990	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 5, 1990	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 28, 1988	Supplement 1Labeling	Approved	None posted
Dec 29, 1986	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 19353
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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