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

Reduces intracranial pressure and treatment of cerebral edema. NDA 20006, held by B Braun. Mannitol.

As of Nov 14, 2026, NDA 20006 (Mannitol 5% In Plastic Container, Mannitol 10% In Plastic Container, Mannitol 15% In Plastic Container), held by B Braun, was first approved by FDA on Jul 26, 1993, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 26, 1993
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Mannitol Injection is indicated for: Reduction of intracranial pressure and treatment of cerebral edema. Reduction of elevated intraocular pressure. Mannitol Injection is an osmotic diuretic, 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 8 submissions below


Sep 24, 2019	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 26, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Sep 24, 2019	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 9, 2019	Supplement 25Labeling · Standard review	Approved	Letter Label
Apr 20, 2005	Supplement 9Labeling	Approved	None posted
Jul 1, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 15, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 7, 2000	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 21, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 26, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20006
Drugs@FDA: Overview at FDA
Company: B. Braun 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