APPLICATION
ANDA086363
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-16
LATEST ACTION
1999-12-03
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
THEOLAIR-SRDiscontinued
THEOPHYLLINE 250MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1999-12-03Manufacturing (CMC) · Supplement 16AP
1998-10-26Manufacturing (CMC) · Supplement 14AP
1998-10-08Manufacturing (CMC) · Supplement 15AP
1998-01-13Manufacturing (CMC) · Supplement 13AP
1991-02-05Manufacturing (CMC) · Supplement 7AP
1991-02-05Manufacturing (CMC) · Supplement 8AP
1990-10-03Labeling · Supplement 10AP
1990-07-02Labeling · Supplement 3AP
1987-07-16OriginalAP
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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