Sorbitol-Mannitol In Plastic Container

NDA 17636, held by Hospira. Mannitol; Sorbitol.

As of Nov 15, 2026, NDA 17636 (Sorbitol-Mannitol In Plastic Container), held by Hospira, was first approved by FDA on Jun 21, 1976, with 42 approved supplements and 0 published complete response letters.

First approved: Jun 21, 1976
Review: Standard
Supplements approved: 42
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 43 submissions below

Date	Submission	Status	Documents
Jun 21, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sorbitol-Mannitol In Plastic Container540MG/100ML;2.7GM/100ML · solution;irrigation	Mannitol; Sorbitol	Discontinued

All 43 submissions, including labeling and manufacturing supplements


Apr 12, 2002	Supplement 48Manufacturing · Standard review	Approved	None posted
Feb 9, 2000	Supplement 47Labeling · Standard review	Approved	None posted
Feb 4, 1998	Supplement 46Manufacturing · Standard review	Approved	None posted
Nov 19, 1997	Supplement 45Labeling · Standard review	Approved	None posted
Aug 27, 1996	Supplement 44Manufacturing · Standard review	Approved	None posted
Aug 24, 1993	Supplement 41Manufacturing · Standard review	Approved	None posted
Jun 30, 1992	Supplement 42Manufacturing · Standard review	Approved	None posted
Nov 25, 1988	Supplement 40Manufacturing · Standard review	Approved	None posted
Aug 29, 1986	Supplement 39Manufacturing · Standard review	Approved	None posted
Jan 18, 1986	Supplement 35Manufacturing · Standard review	Approved	None posted
Oct 29, 1985	Supplement 38Manufacturing · Standard review	Approved	None posted
Jun 17, 1985	Supplement 36Manufacturing · Standard review	Approved	None posted
Oct 22, 1984	Supplement 34Manufacturing · Standard review	Approved	None posted
Sep 21, 1984	Supplement 31Manufacturing · Standard review	Approved	None posted
Aug 25, 1984	Supplement 32Manufacturing · Standard review	Approved	None posted
Mar 15, 1984	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 1, 1984	Supplement 29Manufacturing · Standard review	Approved	None posted
Jun 14, 1982	Supplement 26Labeling · Standard review	Approved	None posted
Jun 10, 1982	Supplement 28Manufacturing · Standard review	Approved	None posted
Nov 6, 1981	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 21, 1981	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 1, 1980	Supplement 25Labeling · Standard review	Approved	None posted
Jul 2, 1980	Supplement 24Labeling · Standard review	Approved	None posted
Jun 16, 1980	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 12, 1980	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 6, 1980	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 3, 1980	Supplement 19Manufacturing · Standard review	Approved	None posted
May 23, 1980	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 20, 1980	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 4, 1979	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 17, 1979	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 31, 1979	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 18, 1979	Supplement 10Manufacturing · Standard review	Approved	None posted
May 1, 1979	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 29, 1978	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 18, 1978	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 23, 1977	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 21, 1977	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 26, 1977	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 5, 1977	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 27, 1976	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 18, 1976	Supplement 2Labeling · Standard review	Approved	None posted
Jun 21, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17636
Drugs@FDA: Overview at FDA
Company: Hospira

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