Diprivan

Controls stress responses only. NDA 19627, held by Fresenius Kabi USA. Propofol.

As of Nov 14, 2026, NDA 19627 (Diprivan), held by Fresenius Kabi USA, was first approved by FDA on Oct 2, 1989, with 38 approved supplements and 0 published complete response letters.

First approved: Oct 2, 1989
Review: Standard
Supplements approved: 38
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: DIPRIVAN is an IV general anesthetic and sedation drug that can be used as described in the table below. Table 3.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 39 submissions below


Feb 23, 2001	Supplement 35Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Oct 26, 1993	Supplement 17Efficacy (new indication or use)	Approved	None posted
Mar 8, 1993	Supplement 10Efficacy (new indication or use)	Approved	None posted
Dec 31, 1991	Supplement 2Efficacy (new indication or use)	Approved	Review
Oct 2, 1989	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Diprivan10MG/ML · injectable;injection	Propofol	Discontinued
Diprivan10MG/ML · injectable;injection	Propofol	RxReference drug

All 39 submissions, including labeling and manufacturing supplements


Nov 21, 2025	Supplement 77Manufacturing	Approved	Letter Label
Aug 31, 2022	Supplement 69Labeling · Standard review	Approved	Letter Label
May 11, 2021	Supplement 72Labeling · Standard review	Approved	Label Letter
Apr 27, 2017	Supplement 66Labeling · Standard review	Approved	Letter Label
Apr 17, 2015	Supplement 64Manufacturing · Standard review	Approved	None posted
Jun 8, 2014	Supplement 62Manufacturing · Standard review	Approved	Label
May 5, 2014	Supplement 58Manufacturing · Standard review	Approved	None posted
Jul 9, 2013	Supplement 60Manufacturing · Standard review	Approved	Label Review Letter
Apr 14, 2008	Supplement 46Labeling · Standard review	Approved	Label Letter
Feb 8, 2007	Supplement 45Labeling · Standard review	Approved	Review Label Letter
Sep 3, 2002	Supplement 42Manufacturing · Standard review	Approved	None posted
Feb 23, 2001	Supplement 35Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Oct 27, 2000	Supplement 40Manufacturing · Standard review	Approved	None posted
Feb 7, 2000	Supplement 37Manufacturing · Standard review	Approved	None posted
Dec 7, 1999	Supplement 36Manufacturing · Standard review	Approved	None posted
Apr 29, 1999	Supplement 34Manufacturing · Standard review	Approved	None posted
Apr 29, 1999	Supplement 31Labeling · Standard review	Approved	None posted
Feb 4, 1999	Supplement 33Manufacturing · Standard review	Approved	None posted
Sep 29, 1998	Supplement 32Manufacturing · Standard review	Approved	None posted
Sep 11, 1997	Supplement 30Manufacturing · Standard review	Approved	None posted
Jun 11, 1996	Supplement 27Manufacturing · Standard review	Approved	Review
Jul 31, 1995	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 21, 1995	Supplement 23Labeling · Standard review	Approved	None posted
Feb 24, 1995	Supplement 20Manufacturing · Standard review	Approved	None posted
Sep 7, 1994	Supplement 19Labeling · Standard review	Approved	None posted
May 9, 1994	Supplement 8Labeling	Approved	None posted
May 6, 1994	Supplement 21Manufacturing · Standard review	Approved	None posted
Oct 26, 1993	Supplement 18Labeling · Standard review	Approved	None posted
Oct 26, 1993	Supplement 17Efficacy (new indication or use)	Approved	None posted
Mar 9, 1993	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 8, 1993	Supplement 10Efficacy (new indication or use)	Approved	None posted
Dec 11, 1992	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 25, 1992	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 31, 1991	Supplement 2Efficacy (new indication or use)	Approved	Review
Jan 18, 1991	Supplement 5Labeling	Approved	None posted
Jan 18, 1991	Supplement 4Labeling	Approved	None posted
Jan 18, 1991	Supplement 3Labeling	Approved	None posted
Jan 18, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 2, 1989	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19627
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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