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 19083, held by B Braun. Theophylline.

As of Nov 13, 2026, NDA 19083 (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 Nov 7, 1984, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 7, 1984
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 7, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Theophylline 0.04% And Dextrose 5% In Plastic Container40MG/100ML · injectable;injection	Theophylline	Discontinued
Theophylline 0.08% And Dextrose 5% In Plastic Container80MG/100ML · injectable;injection	Theophylline	Discontinued
Theophylline 0.16% And Dextrose 5% In Plastic Container160MG/100ML · injectable;injection	Theophylline	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 15, 1990	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 18, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 7, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19083
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