APPLICATION
ANDA089540
TYPE
ANDA
ORIGINAL APPROVAL
1989-05-10
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
SLO-BIDDiscontinued
THEOPHYLLINE 125MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 12AP
1996-03-19Manufacturing (CMC) · Supplement 10AP
1990-11-20Labeling · Supplement 7AP
1990-08-10Labeling · Supplement 6AP
1990-05-30Manufacturing (CMC) · Supplement 5AP
1990-05-30Manufacturing (CMC) · Supplement 3AP
1990-05-30Manufacturing (CMC) · Supplement 4AP
1990-03-27Manufacturing (CMC) · Supplement 1AP
1989-07-27Manufacturing (CMC) · Supplement 2AP
1989-05-10OriginalAP
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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