APPLICATION
ANDA088383
TYPE
ANDA
ORIGINAL APPROVAL
1997-03-14
LATEST ACTION
1997-03-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
SOMOPHYLLIN-CRTDiscontinued
THEOPHYLLINE 300MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1997-03-14Labeling · Supplement 9AP
1997-03-14Labeling · Supplement 21AP
1997-03-14Labeling · Supplement 13AP
1997-03-14Labeling · Supplement 6AP
1997-03-14OriginalAP
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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