← FDA DRUG APPROVALS
FDA NDA · NDA019212
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: B BRAUN
APPLICATION
NDA019212
TYPE
NDA
ORIGINAL APPROVAL
1984-11-07
LATEST ACTION
1992-04-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 400MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 4MG/ML · INJECTABLE · INJECTION
THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 200MG/100ML · INJECTABLE · INJECTION
Approval history
1992-04-23Manufacturing (CMC) · Supplement 7 · standardAP
1989-03-09Manufacturing (CMC) · Supplement 5 · standardAP
1985-08-13Manufacturing (CMC) · Supplement 1 · standardAP
1984-11-07Type 5 - New Formulation or New Manufacturer · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.