Mannitol 25%

Treats oliguric phase of acute renal failure before irreversible renal failure becomes…. ANDA 80677, held by Fresenius Kabi USA. Mannitol.

As of Nov 14, 2026, ANDA 80677 (Mannitol 25%), held by Fresenius Kabi USA, was first approved by FDA on Aug 11, 1972, with 14 approved supplements and 0 published complete response letters.

First approved: Aug 11, 1972
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For Intravenous Injection Mannitol Injection, USP is indicated for the following therapeutic uses:

The promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.
The reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass.
The reduction of elevated intraocular pressure when it cannot be lowered by other means.
The promotion of urinary excretion of toxic substances. For Urologic Irrigation Mannitol solution, 2.5% is indicated as an irrigation solution in transurethral prostatic resection or other transurethral surgical procedures.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Aug 11, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mannitol 25%12.5GM/50ML · injectable;injection	Mannitol	Rx

All 15 submissions, including labeling and manufacturing supplements


Aug 13, 1999	Supplement 30Manufacturing	Approved	None posted
Jul 14, 1995	Supplement 35Manufacturing	Approved	None posted
Dec 6, 1994	Supplement 31Manufacturing	Approved	None posted
Apr 8, 1993	Supplement 34Labeling	Approved	None posted
May 1, 1992	Supplement 33Labeling	Approved	None posted
Jun 19, 1991	Supplement 32Labeling	Approved	None posted
Jan 11, 1989	Supplement 28Manufacturing	Approved	None posted
Jan 11, 1989	Supplement 29Manufacturing	Approved	None posted
Dec 12, 1985	Supplement 26Manufacturing	Approved	None posted
Oct 18, 1985	Supplement 25Manufacturing	Approved	None posted
Jan 10, 1985	Supplement 23Manufacturing	Approved	None posted
Sep 20, 1983	Supplement 22Manufacturing	Approved	None posted
Nov 8, 1982	Supplement 19Manufacturing	Approved	None posted
Nov 1, 1982	Supplement 20Manufacturing	Approved	None posted
Aug 11, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80677
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