Theophylline In Dextrose 5% In Plastic Container

NDA 19211, held by Hospira Inc. Theophylline.

As of Nov 14, 2026, NDA 19211 (Theophylline In Dextrose 5% In Plastic Container), held by Hospira Inc, was first approved by FDA on Dec 14, 1984, with 26 approved supplements and 0 published complete response letters.

First approved: Dec 14, 1984
Review: Standard
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Dec 14, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

7 strengths and forms


Theophylline In Dextrose 5% In Plastic Container40MG/100ML · injectable;injection	Theophylline	DiscontinuedReference drug
Theophylline In Dextrose 5% In Plastic Container80MG/100ML · injectable;injection	Theophylline	Discontinued
Theophylline In Dextrose 5% In Plastic Container160MG/100ML · injectable;injection	Theophylline	DiscontinuedReference drug
Theophylline In Dextrose 5% In Plastic Container200MG/100ML · injectable;injection	Theophylline	Discontinued
Theophylline In Dextrose 5% In Plastic Container400MG/100ML · injectable;injection	Theophylline	Discontinued
Theophylline In Dextrose 5% In Plastic Container320MG/100ML · injectable;injection	Theophylline	DiscontinuedReference drug
Theophylline In Dextrose 5% In Plastic Container4MG/ML · injectable;injection	Theophylline	DiscontinuedReference drug

All 27 submissions, including labeling and manufacturing supplements


Mar 26, 2009	Supplement 42Labeling · Standard review	Approved	Label Letter
Oct 31, 2008	Supplement 40Labeling · Standard review	Approved	Label Letter
Nov 1, 2002	Supplement 30Manufacturing · Standard review	Approved	None posted
Nov 10, 1998	Supplement 28Manufacturing · Standard review	Approved	None posted
Jul 10, 1997	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 22, 1996	Supplement 26Manufacturing · Standard review	Approved	None posted
Jul 9, 1996	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 9, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 13, 1996	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 5, 1996	Supplement 25Labeling · Standard review	Approved	None posted
Feb 2, 1996	Supplement 18Labeling · Standard review	Approved	None posted
Aug 21, 1995	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 13, 1992	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 23, 1992	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 23, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 2, 1991	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 20, 1988	Supplement 11Labeling	Approved	None posted
Jan 20, 1988	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 26, 1986	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 31, 1986	Supplement 8Labeling	Approved	None posted
Aug 29, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 11, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 8, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 24, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 14, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19211
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