Sodium Phosphates In Plastic Container

NDA 18892, held by Hospira. Sodium Phosphate, Dibasic, Heptahydrate; Sodium Phosphate, Monobasic, Monohydrate.

As of Nov 13, 2026, NDA 18892 (Sodium Phosphates In Plastic Container), held by Hospira, was first approved by FDA on May 10, 1983, with 22 approved supplements and 0 published complete response letters.

First approved: May 10, 1983
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
May 10, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sodium Phosphates In Plastic Container4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) · solution;intravenous	Sodium Phosphate, Dibasic, Heptahydrate; Sodium Phosphate, Monobasic, Monohydrate	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Nov 30, 2023	Supplement 38Manufacturing	Approved	Review
Jul 17, 2023	Supplement 37Manufacturing	Approved	Review
Jan 12, 2015	Supplement 31Manufacturing · Standard review	Approved	None posted
Jun 12, 2014	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 14, 2002	Supplement 21Labeling · Standard review	Approved	Letter
Feb 16, 2001	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 16, 2000	Supplement 18Labeling · Standard review	Approved	None posted
Aug 31, 1999	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 22, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 19, 1997	Supplement 16Labeling · Standard review	Approved	None posted
Jan 17, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 18, 1989	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 21, 1988	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 11, 1987	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 26, 1987	Supplement 10Labeling	Approved	None posted
Oct 21, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 24, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 15, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 22, 1984	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 17, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 24, 1983	Supplement 2Labeling	Approved	None posted
May 10, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18892
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