Aminophylline In Sodium Chloride 0.45% In Plastic Container

NDA 18924, held by Hospira. Aminophylline.

As of Nov 13, 2026, NDA 18924 (Aminophylline In Sodium Chloride 0.45% In Plastic Container), held by Hospira, was first approved by FDA on Dec 12, 1984, with 18 approved supplements and 0 published complete response letters.

First approved: Dec 12, 1984
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Dec 12, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Aminophylline In Sodium Chloride 0.45% In Plastic Container100MG/100ML · injectable;injection	Aminophylline	Discontinued
Aminophylline In Sodium Chloride 0.45% In Plastic Container200MG/100ML · injectable;injection	Aminophylline	Discontinued
Aminophylline In Sodium Chloride 0.45% In Plastic Container400MG/100ML · injectable;injection	Aminophylline	Discontinued
Aminophylline In Sodium Chloride 0.45% In Plastic Container500MG/100ML · injectable;injection	Aminophylline	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Nov 10, 1998	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 10, 1997	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 2, 1997	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 22, 1996	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 9, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 9, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 13, 1996	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 13, 1992	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 5, 1992	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 5, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 2, 1991	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 26, 1986	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 29, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 29, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 8, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 10, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 12, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18924
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