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FDA NDA · NDA018924
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
NDA018924
TYPE
NDA
ORIGINAL APPROVAL
1984-12-12
LATEST ACTION
1998-11-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDiscontinued
AMINOPHYLLINE 200MG/100ML · INJECTABLE · INJECTION
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDiscontinued
AMINOPHYLLINE 400MG/100ML · INJECTABLE · INJECTION
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDiscontinued
AMINOPHYLLINE 100MG/100ML · INJECTABLE · INJECTION
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDiscontinued
AMINOPHYLLINE 500MG/100ML · INJECTABLE · INJECTION
Approval history
1998-11-10Manufacturing (CMC) · Supplement 21 · standardAP
1997-07-10Manufacturing (CMC) · Supplement 20 · standardAP
1997-04-02Manufacturing (CMC) · Supplement 19 · standardAP
1996-07-22Manufacturing (CMC) · Supplement 18 · standardAP
1996-07-09Manufacturing (CMC) · Supplement 16 · standardAP
1996-07-09Manufacturing (CMC) · Supplement 15 · standardAP
1996-02-13Manufacturing (CMC) · Supplement 17 · standardAP
1992-07-13Manufacturing (CMC) · Supplement 13 · standardAP
1992-06-05Manufacturing (CMC) · Supplement 7 · standardAP
1992-06-05Manufacturing (CMC) · Supplement 11 · standardAP
1991-12-02Manufacturing (CMC) · Supplement 12 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 10 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 6 · standardAP
1986-08-29Manufacturing (CMC) · Supplement 3 · standardAP
1986-08-29Manufacturing (CMC) · Supplement 4 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 5 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 1 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 2 · standardAP
1984-12-12Type 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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