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FDA NDA · NDA018649
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA018649
TYPE
NDA
ORIGINAL APPROVAL
1982-07-26
LATEST ACTION
2008-10-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 320MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 200MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 80MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 4MG/ML · INJECTABLE · INJECTION
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 400MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 160MG/100ML · INJECTABLE · INJECTION
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
THEOPHYLLINE 40MG/100ML · INJECTABLE · INJECTION
Approval history
1999-11-23Manufacturing (CMC) · Supplement 38 · standardAP
1999-07-16Manufacturing (CMC) · Supplement 37 · standardAP
1997-12-22Manufacturing (CMC) · Supplement 36 · standardAP
1997-05-02Manufacturing (CMC) · Supplement 35 · standardAP
1996-09-04Labeling · Supplement 34 · standardAP
1994-09-26Manufacturing (CMC) · Supplement 31 · standardAP
1994-07-27Manufacturing (CMC) · Supplement 33 · standardAP
1994-02-25Manufacturing (CMC) · Supplement 32 · standardAP
1993-05-27Manufacturing (CMC) · Supplement 30 · standardAP
1992-11-03Manufacturing (CMC) · Supplement 27 · standardAP
1992-10-16Manufacturing (CMC) · Supplement 26 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 28 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 25 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 24 · standardAP
1987-11-18Manufacturing (CMC) · Supplement 22 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 21 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 19 · standardAP
1986-04-15Labeling · Supplement 5AP
1986-02-27Manufacturing (CMC) · Supplement 15 · standardAP
1985-11-13Manufacturing (CMC) · Supplement 9 · standardAP
1985-11-13Labeling · Supplement 10AP
1985-09-14Manufacturing (CMC) · Supplement 13 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 8 · standardAP
1985-04-26Manufacturing (CMC) · Supplement 14 · standardAP
1985-04-10Labeling · Supplement 11AP
1984-10-04Manufacturing (CMC) · Supplement 6 · standardAP
1984-04-30Manufacturing (CMC) · Supplement 7 · standardAP
1984-04-30Labeling · Supplement 3AP
1984-02-28Manufacturing (CMC) · Supplement 4 · standardAP
1982-09-02Manufacturing (CMC) · Supplement 1 · standardAP
1982-07-26Type 4 - New Combination · 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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