APPLICATION
ANDA040052
TYPE
ANDA
ORIGINAL APPROVAL
1994-02-14
LATEST ACTION
1999-05-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
THEOPHYLLINEDiscontinued
THEOPHYLLINE 200MG · CAPSULE, EXTENDED RELEASE · ORAL
THEOPHYLLINEDiscontinued
THEOPHYLLINE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
THEOPHYLLINEDiscontinued
THEOPHYLLINE 300MG · CAPSULE, EXTENDED RELEASE · ORAL
THEOPHYLLINEDiscontinued
THEOPHYLLINE 125MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1999-05-27Labeling · Supplement 3AP
1998-01-28Manufacturing (CMC) · Supplement 7AP
1997-09-22Manufacturing (CMC) · Supplement 6AP
1997-03-11Manufacturing (CMC) · Supplement 5AP
1994-07-11Manufacturing (CMC) · Supplement 2AP
1994-05-19Manufacturing (CMC) · Supplement 1AP
1994-02-14OriginalAP
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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