Sufenta Preservative Free

NDA 19050, held by Rising. Sufentanil Citrate.

As of Nov 13, 2026, NDA 19050 (Sufenta Preservative Free), held by Rising, was first approved by FDA on May 4, 1984, with 29 approved supplements and 0 published complete response letters.

First approved: May 4, 1984
Review: Priority
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below


Mar 19, 1993	Supplement 17Efficacy (new indication or use)	Approved	None posted
May 4, 1984	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sufenta Preservative FreeEQ 0.05MG BASE/ML · injectable;injection	Sufentanil Citrate	RxReference drug

All 30 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 45Labeling · Standard review	Approved	Label Letter
Dec 15, 2023	Supplement 43Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 37Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 34Labeling · Standard review	Approved	Label Letter
Mar 20, 2014	Supplement 32Labeling · Standard review	Approved	Label Letter
Jun 4, 2007	Supplement 31Labeling · Standard review	Approved	Label Letter
Aug 27, 2001	Supplement 25Labeling · Standard review	Approved	None posted
May 25, 1999	Supplement 28Manufacturing · Priority review	Approved	None posted
May 26, 1998	Supplement 27Manufacturing · Priority review	Approved	None posted
May 1, 1998	Supplement 26Manufacturing · Priority review	Approved	None posted
Aug 12, 1997	Supplement 23Manufacturing · Priority review	Approved	None posted
Jun 21, 1996	Supplement 24Labeling · Standard review	Approved	None posted
Feb 22, 1995	Supplement 22Manufacturing · Priority review	Approved	None posted
Mar 23, 1994	Supplement 20Manufacturing · Priority review	Approved	None posted
Mar 23, 1994	Supplement 19Manufacturing · Priority review	Approved	None posted
Mar 23, 1994	Supplement 18Manufacturing · Priority review	Approved	None posted
Mar 19, 1993	Supplement 17Efficacy (new indication or use)	Approved	None posted
Nov 10, 1992	Supplement 21Manufacturing · Priority review	Approved	None posted
Oct 5, 1990	Supplement 14Manufacturing · Priority review	Approved	None posted
Apr 29, 1987	Supplement 11Manufacturing · Priority review	Approved	None posted
Nov 14, 1986	Supplement 10Labeling	Approved	None posted
Nov 14, 1986	Supplement 9Manufacturing · Priority review	Approved	None posted
Aug 6, 1986	Supplement 8Manufacturing · Priority review	Approved	None posted
Jun 20, 1986	Supplement 4Manufacturing · Priority review	Approved	None posted
Mar 18, 1986	Supplement 7Manufacturing · Priority review	Approved	None posted
Mar 18, 1986	Supplement 6Labeling	Approved	None posted
Aug 21, 1985	Supplement 3Labeling	Approved	None posted
Aug 21, 1985	Supplement 2Manufacturing · Priority review	Approved	None posted
Sep 10, 1984	Supplement 1Manufacturing · Priority review	Approved	None posted
May 4, 1984	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19050
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