APPLICATION
NDA002386
TYPE
NDA
ORIGINAL APPROVAL
1940-04-19
LATEST ACTION
1991-08-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMINOPHYLLINDiscontinued
AMINOPHYLLINE 100MG · TABLET · ORAL
AMINOPHYLLINDiscontinued
AMINOPHYLLINE 200MG · TABLET · ORAL
Approval history
1991-08-27Labeling · Supplement 15 · standardAP
1991-08-27Labeling · Supplement 13 · standardAP
1991-08-27Labeling · Supplement 12 · standardAP
1989-08-14Manufacturing (CMC) · Supplement 14 · standardAP
1983-12-09Manufacturing (CMC) · Supplement 11 · standardAP
1981-04-14Manufacturing (CMC) · Supplement 9 · standardAP
1981-04-14Labeling · Supplement 10 · standardAP
1980-09-15Labeling · Supplement 5 · standardAP
1980-06-13Manufacturing (CMC) · Supplement 6 · standardAP
1980-06-13Manufacturing (CMC) · Supplement 7 · standardAP
1980-05-23Labeling · Supplement 8 · standardAP
1980-01-18Manufacturing (CMC) · Supplement 4 · standardAP
1977-08-01Labeling · Supplement 2 · standardAP
1977-08-01Manufacturing (CMC) · Supplement 3 · standardAP
1977-08-01Manufacturing (CMC) · Supplement 1 · standardAP
1940-04-19Type 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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