Physiosol In Plastic Container

NDA 17637, held by Otsuka Icu Medcl. Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate.

As of Nov 14, 2026, NDA 17637 (Physiosol In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Feb 8, 1978, with 41 approved supplements and 0 published complete response letters.

First approved: Feb 8, 1978
Review: Standard
Supplements approved: 41
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 42 submissions below

Date	Submission	Status	Documents
Feb 8, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Physiosol In Plastic Container30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML · solution;irrigation	Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate	Rx

All 42 submissions, including labeling and manufacturing supplements


Jun 12, 2014	Supplement 61Manufacturing · Standard review	Approved	None posted
Feb 23, 2000	Supplement 46Labeling · Standard review	Approved	None posted
Jun 4, 1999	Supplement 47Manufacturing · Standard review	Approved	None posted
May 12, 1998	Supplement 44Labeling · Standard review	Approved	None posted
Feb 4, 1998	Supplement 45Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 43Manufacturing · Standard review	Approved	None posted
Aug 24, 1993	Supplement 40Manufacturing · Standard review	Approved	None posted
Jun 30, 1992	Supplement 41Manufacturing · Standard review	Approved	None posted
Nov 25, 1988	Supplement 39Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Supplement 38Manufacturing · Standard review	Approved	None posted
Jan 18, 1986	Supplement 35Manufacturing · Standard review	Approved	None posted
Oct 29, 1985	Supplement 37Manufacturing · Standard review	Approved	None posted
Nov 9, 1984	Supplement 34Manufacturing · Standard review	Approved	None posted
Oct 22, 1984	Supplement 33Manufacturing · Standard review	Approved	None posted
Aug 25, 1984	Supplement 31Manufacturing · Standard review	Approved	None posted
Mar 15, 1984	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 1, 1984	Supplement 28Manufacturing · Standard review	Approved	None posted
Jul 8, 1982	Supplement 25Labeling	Approved	None posted
Jun 18, 1982	Supplement 29Manufacturing · Standard review	Approved	None posted
Jun 10, 1982	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 6, 1981	Supplement 26Manufacturing · Standard review	Approved	None posted
Jul 21, 1981	Supplement 18Manufacturing · Standard review	Approved	None posted
Oct 1, 1980	Supplement 24Labeling	Approved	None posted
Sep 8, 1980	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 6, 1980	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 6, 1980	Supplement 20Manufacturing · Standard review	Approved	None posted
May 23, 1980	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 20, 1980	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 4, 1979	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 31, 1979	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 18, 1979	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 30, 1979	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 2, 1979	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 5, 1979	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 1, 1978	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 22, 1978	Supplement 7Labeling	Approved	None posted
Nov 22, 1978	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 8, 1978	Supplement 5Labeling	Approved	None posted
Sep 8, 1978	Supplement 2Labeling	Approved	None posted
Aug 29, 1978	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 30, 1978	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 8, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17637
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