← FDA DRUG APPROVALS

FDA NDA · NDA019627

DIPRIVAN

propofol

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA019627
TYPE
NDA
ORIGINAL APPROVAL
1989-10-02
LATEST ACTION
2025-11-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

DIPRIVANDiscontinued
PROPOFOL 10MG/ML · INJECTABLE · INJECTION
DIPRIVAN · ReferencePrescription
PROPOFOL 10MG/ML · INJECTABLE · INJECTION

Approval history

2025-11-21Manufacturing (CMC) · Supplement 77 — Letter ↗AP
2022-08-31Labeling · Supplement 69 · standard — Letter ↗AP
2021-05-11Labeling · Supplement 72 · standard — Letter ↗AP
2017-04-27Labeling · Supplement 66 · standard — Letter ↗AP
2015-04-17Manufacturing (CMC) · Supplement 64 · standardAP
2014-06-08Manufacturing (CMC) · Supplement 62 · standard — Label ↗AP
2014-05-05Manufacturing (CMC) · Supplement 58 · standardAP
2013-07-09Manufacturing (CMC) · Supplement 60 · standard — Review ↗AP
2008-04-14Labeling · Supplement 46 · standard — Label ↗AP
2007-02-08Labeling · Supplement 45 · standard — Label ↗AP
2002-09-03Manufacturing (CMC) · Supplement 42 · standardAP
2001-02-23Efficacy · Supplement 35 · standard — Label ↗AP
2000-10-27Manufacturing (CMC) · Supplement 40 · standardAP
2000-02-07Manufacturing (CMC) · Supplement 37 · standardAP
1999-12-07Manufacturing (CMC) · Supplement 36 · standardAP
1999-04-29Manufacturing (CMC) · Supplement 34 · standardAP
1999-04-29Labeling · Supplement 31 · standardAP
1999-02-04Manufacturing (CMC) · Supplement 33 · standardAP
1998-09-29Manufacturing (CMC) · Supplement 32 · standardAP
1997-09-11Manufacturing (CMC) · Supplement 30 · standardAP
1996-06-11Manufacturing (CMC) · Supplement 27 · standard — Review ↗AP
1995-07-31Manufacturing (CMC) · Supplement 24 · standardAP
1995-04-21Labeling · Supplement 23 · standardAP
1995-02-24Manufacturing (CMC) · Supplement 20 · standardAP
1994-09-07Labeling · Supplement 19 · standardAP
1994-05-09Labeling · Supplement 8AP
1994-05-06Manufacturing (CMC) · Supplement 21 · standardAP
1993-10-26Labeling · Supplement 18 · standardAP
1993-10-26Efficacy · Supplement 17AP
1993-03-09Manufacturing (CMC) · Supplement 6 · standardAP
1993-03-08Efficacy · Supplement 10AP
1992-12-11Manufacturing (CMC) · Supplement 14 · standardAP
1992-02-25Manufacturing (CMC) · Supplement 12 · standardAP
1991-12-31Efficacy · Supplement 2 — Review ↗AP
1991-01-18Manufacturing (CMC) · Supplement 1 · standardAP
1991-01-18Labeling · Supplement 4AP
1991-01-18Labeling · Supplement 5AP
1991-01-18Labeling · Supplement 3AP
1989-10-02Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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