APPLICATION
ANDA085498
TYPE
ANDA
ORIGINAL APPROVAL
1983-01-03
LATEST ACTION
1997-10-14
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued
Products
TRUPHYLLINEDiscontinued
AMINOPHYLLINE 250MG · SUPPOSITORY · RECTAL
TRUPHYLLINEDiscontinued
AMINOPHYLLINE 500MG · SUPPOSITORY · RECTAL
Approval history
1997-10-14Labeling · Supplement 14AP
1992-05-01Labeling · Supplement 13AP
1991-07-15Labeling · Supplement 12AP
1990-06-18Labeling · Supplement 11AP
1988-12-29Labeling · Supplement 10AP
1985-11-05Manufacturing (CMC) · Supplement 8AP
1983-05-27Manufacturing (CMC) · Supplement 5AP
1983-03-22Manufacturing (CMC) · Supplement 2AP
1983-03-22Manufacturing (CMC) · Supplement 1AP
1983-01-03OriginalAP
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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