Mannitol 25%

ANDA 83051, held by Intl Medication. Mannitol.

As of Nov 13, 2026, ANDA 83051 (Mannitol 25%), held by Intl Medication, was first approved by FDA on Aug 29, 1975, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 29, 1975
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Aug 29, 1975	Original application	Approved	None posted

Products

1 strengths and forms

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

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 14, 1998	Supplement 15Manufacturing	Approved	None posted
Sep 19, 1995	Supplement 17Manufacturing	Approved	None posted
Jun 17, 1994	Supplement 16Manufacturing	Approved	None posted
Oct 29, 1993	Supplement 14Manufacturing	Approved	None posted
Dec 17, 1992	Supplement 12Manufacturing	Approved	None posted
Dec 7, 1992	Supplement 11Labeling	Approved	None posted
Dec 7, 1992	Supplement 13Labeling	Approved	None posted
Jan 29, 1987	Supplement 7Manufacturing	Approved	None posted
Aug 29, 1985	Supplement 5Manufacturing	Approved	None posted
Aug 29, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 83051
Drugs@FDA: Overview at FDA
Company: International Medication Systems

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters