Theophylline 0.04% And Dextrose 5% In Plastic Container, Theophylline 0.08% And Dextrose 5% In Plastic Container, Theophylline 0.16% And Dextrose 5% In Plastic Container

NDA 19826, held by B Braun. Theophylline.

As of Nov 13, 2026, NDA 19826 (Theophylline 0.04% And Dextrose 5% In Plastic Container, Theophylline 0.08% And Dextrose 5% In Plastic Container, Theophylline 0.16% And Dextrose 5% In Plastic Container), held by B Braun, was first approved by FDA on Aug 14, 1992, with 12 approved supplements and 0 published complete response letters.

First approved: Aug 14, 1992
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Aug 14, 1992	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

6 strengths and forms


Theophylline 0.04% And Dextrose 5% In Plastic Container40MG/100ML · injectable;injection	Theophylline	DiscontinuedReference drug
Theophylline 0.08% And Dextrose 5% In Plastic Container80MG/100ML · injectable;injection	Theophylline	DiscontinuedReference drug
Theophylline 0.16% And Dextrose 5% In Plastic Container160MG/100ML · injectable;injection	Theophylline	DiscontinuedReference drug
Theophylline 0.2% And Dextrose 5% In Plastic Container200MG/100ML · injectable;injection	Theophylline	Discontinued
Theophylline 0.4% And Dextrose 5% In Plastic Container400MG/100ML · injectable;injection	Theophylline	Discontinued
Theophylline 0.32% And Dextrose 5% In Plastic Container320MG/100ML · injectable;injection	Theophylline	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


Aug 22, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 17, 2012	Supplement 23Labeling	Approved	Letter Label
Oct 17, 2008	Supplement 21Labeling · Standard review	Approved	Letter
Apr 8, 2008	Supplement 20Labeling · Standard review	Approved	Letter
Jul 12, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 5, 2002	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 12, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 4, 1998	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 24, 1996	Supplement 7Labeling · Standard review	Approved	None posted
Jun 19, 1995	Supplement 2Labeling · Standard review	Approved	None posted
Dec 15, 1994	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 6, 1993	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 14, 1992	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19826
Drugs@FDA: Overview at FDA
Company: B. Braun 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