APPLICATION
ANDA086826
TYPE
ANDA
ORIGINAL APPROVAL
1998-02-06
LATEST ACTION
1998-02-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
ELIXOPHYLLIN SRDiscontinued
THEOPHYLLINE 250MG · CAPSULE, EXTENDED RELEASE · ORAL
ELIXOPHYLLIN SRDiscontinued
THEOPHYLLINE 125MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1998-02-06OriginalAP
1995-01-27Labeling · Supplement 3AP
1993-07-27Labeling · Supplement 5AP
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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