APPLICATION
ANDA087194
TYPE
ANDA
ORIGINAL APPROVAL
1981-09-17
LATEST ACTION
1997-03-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
SOMOPHYLLIN-CRTDiscontinued
THEOPHYLLINE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1997-03-13Labeling · Supplement 34AP
1997-03-13Labeling · Supplement 26AP
1997-03-13Labeling · Supplement 18AP
1990-11-20Labeling · Supplement 21AP
1981-09-17OriginalAP
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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