Theophylline And Dextrose 5% In Plastic Container

NDA 18649, held by Baxter Hlthcare. Theophylline.

As of Nov 14, 2026, NDA 18649 (Theophylline And Dextrose 5% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Jul 26, 1982, with 32 approved supplements and 0 published complete response letters.

First approved: Jul 26, 1982
Review: Standard
Supplements approved: 32
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Jul 26, 1982	Original applicationNew combination · Standard review	Approved	None posted

Products

7 strengths and forms


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

All 33 submissions, including labeling and manufacturing supplements


Oct 17, 2008	Supplement 43Labeling · Standard review	Approved	Letter
Dec 31, 2003	Supplement 40Labeling · Standard review	Approved	Label Letter
Nov 23, 1999	Supplement 38Manufacturing · Standard review	Approved	None posted
Jul 16, 1999	Supplement 37Manufacturing · Standard review	Approved	None posted
Dec 22, 1997	Supplement 36Manufacturing · Standard review	Approved	None posted
May 2, 1997	Supplement 35Manufacturing · Standard review	Approved	None posted
Sep 4, 1996	Supplement 34Labeling · Standard review	Approved	None posted
Sep 26, 1994	Supplement 31Manufacturing · Standard review	Approved	None posted
Jul 27, 1994	Supplement 33Manufacturing · Standard review	Approved	None posted
Feb 25, 1994	Supplement 32Manufacturing · Standard review	Approved	None posted
May 27, 1993	Supplement 30Manufacturing · Standard review	Approved	None posted
Nov 3, 1992	Supplement 27Manufacturing · Standard review	Approved	None posted
Oct 16, 1992	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 30, 1991	Supplement 28Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 12, 1989	Supplement 24Manufacturing · Standard review	Approved	None posted
Nov 18, 1987	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 25, 1987	Supplement 21Manufacturing · Standard review	Approved	None posted
May 28, 1987	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 15, 1986	Supplement 5Labeling	Approved	None posted
Feb 27, 1986	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 13, 1985	Supplement 10Labeling	Approved	None posted
Nov 13, 1985	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 14, 1985	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 13, 1985	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 26, 1985	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 10, 1985	Supplement 11Labeling	Approved	None posted
Oct 4, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 30, 1984	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 30, 1984	Supplement 3Labeling	Approved	None posted
Feb 28, 1984	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 2, 1982	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 26, 1982	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 18649
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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