← FDA DRUG APPROVALS
FDA NDA · NDA019826
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: B BRAUN
APPLICATION
NDA019826
TYPE
NDA
ORIGINAL APPROVAL
1992-08-14
LATEST ACTION
2014-08-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 400MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
THEOPHYLLINE 160MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
THEOPHYLLINE 40MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
THEOPHYLLINE 320MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 200MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
THEOPHYLLINE 80MG/100ML · INJECTABLE · INJECTION
Approval history
2014-08-22Manufacturing (CMC) · Supplement 22 · standardAP
2002-07-12Manufacturing (CMC) · Supplement 13 · standardAP
2002-03-05Manufacturing (CMC) · Supplement 11 · standardAP
2001-03-12Manufacturing (CMC) · Supplement 10 · standardAP
1998-08-04Manufacturing (CMC) · Supplement 8 · standardAP
1996-07-24Labeling · Supplement 7 · standardAP
1995-06-19Labeling · Supplement 2 · standardAP
1994-12-15Manufacturing (CMC) · Supplement 3 · standardAP
1993-10-06Manufacturing (CMC) · Supplement 1 · standardAP
1992-08-14Type 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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