APPLICATION
ANDA089131
TYPE
ANDA
ORIGINAL APPROVAL
1986-06-25
LATEST ACTION
2002-01-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
THEO-DURDiscontinued
THEOPHYLLINE 450MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2002-01-10Labeling · Supplement 23AP
1997-08-18Labeling · Supplement 18AP
1997-08-18Labeling · Supplement 19AP
1996-07-17Labeling · Supplement 17AP
1990-11-21Labeling · Supplement 16AP
1990-11-21Manufacturing (CMC) · Supplement 15AP
1989-10-26Labeling · Supplement 11AP
1988-06-22Manufacturing (CMC) · Supplement 13AP
1988-06-22Manufacturing (CMC) · Supplement 12AP
1987-08-20Manufacturing (CMC) · Supplement 7AP
1987-08-20Manufacturing (CMC) · Supplement 5AP
1987-08-20Manufacturing (CMC) · Supplement 3AP
1987-08-20Manufacturing (CMC) · Supplement 10AP
1987-08-20Manufacturing (CMC) · Supplement 4AP
1987-08-20Manufacturing (CMC) · Supplement 2AP
1986-06-25OriginalAP
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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