Mannitol 5% In Plastic Container, Mannitol 10% In Plastic Container, Mannitol 15% In Plastic Container

Treats cerebral edema. NDA 19603, held by Otsuka Icu Medcl. Mannitol.

As of Nov 13, 2026, NDA 19603 (Mannitol 5% In Plastic Container, Mannitol 10% In Plastic Container, Mannitol 15% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Jan 8, 1987, with 18 approved supplements and 0 published complete response letters.

First approved: Jan 8, 1987
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Mannitol Injection is indicated for the reduction of: intracranial pressure and treatment of cerebral edema; elevated intraocular pressure.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Apr 29, 2020	Supplement 40Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 8, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Mannitol 5% In Plastic Container5GM/100ML · injectable;injection	Mannitol	Discontinued
Mannitol 10% In Plastic Container10GM/100ML · injectable;injection	Mannitol	Discontinued
Mannitol 15% In Plastic Container15GM/100ML · injectable;injection	Mannitol	Discontinued
Mannitol 20% In Plastic Container20GM/100ML · injectable;injection	Mannitol	Rx

All 19 submissions, including labeling and manufacturing supplements


Apr 29, 2020	Supplement 40Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 9, 2019	Supplement 38Labeling · Standard review	Approved	Label
Jul 10, 2000	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 1, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 11, 1997	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 6, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 4, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 14, 1995	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 25, 1994	Supplement 10Labeling	Approved	None posted
Jan 28, 1992	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 10, 1991	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 4, 1990	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 11, 1990	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 8, 1990	Supplement 2Labeling	Approved	None posted
Jan 8, 1990	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 8, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19603
Drugs@FDA: Overview at FDA
Company: Otsuka ICU Medical

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