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FDA NDA · NDA019083
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: B BRAUN
APPLICATION
NDA019083
TYPE
NDA
ORIGINAL APPROVAL
1984-11-07
LATEST ACTION
1990-10-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 80MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 160MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 40MG/100ML · INJECTABLE · INJECTION
Approval history
1990-10-15Manufacturing (CMC) · Supplement 5 · standardAP
1985-09-18Manufacturing (CMC) · Supplement 2 · 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.
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