APPLICATION
ANDA088369
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 200MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1999-12-03Manufacturing (CMC) · Supplement 10AP
1998-10-26Manufacturing (CMC) · Supplement 8AP
1998-10-08Manufacturing (CMC) · Supplement 9AP
1998-05-29Labeling · Supplement 6AP
1998-01-13Manufacturing (CMC) · Supplement 7AP
1991-01-07Labeling · Supplement 4AP
1989-04-28Manufacturing (CMC) · Supplement 1AP
1989-04-28Manufacturing (CMC) · Supplement 2AP
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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