APPLICATION
ANDA085202
TYPE
ANDA
ORIGINAL APPROVAL
1979-11-14
LATEST ACTION
1999-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SLO-PHYLLINDiscontinued
THEOPHYLLINE 100MG · TABLET · ORAL
Approval history
1999-04-29Manufacturing (CMC) · Supplement 24AP
1990-11-27Labeling · Supplement 21AP
1990-07-26Labeling · Supplement 20AP
1990-06-18Manufacturing (CMC) · Supplement 18AP
1990-06-18Manufacturing (CMC) · Supplement 19AP
1985-11-01Manufacturing (CMC) · Supplement 15AP
1985-07-26Manufacturing (CMC) · Supplement 10AP
1984-07-30Manufacturing (CMC) · Supplement 13AP
1984-01-10Manufacturing (CMC) · Supplement 12AP
1983-03-03Manufacturing (CMC) · Supplement 9AP
1982-07-15Manufacturing (CMC) · Supplement 7AP
1982-07-15Manufacturing (CMC) · Supplement 5AP
1982-07-15Manufacturing (CMC) · Supplement 8AP
1982-07-15Manufacturing (CMC) · Supplement 6AP
1979-11-14OriginalAP
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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