APPLICATION
ANDA089763
TYPE
ANDA
ORIGINAL APPROVAL
1990-04-30
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
THEOPHYLLINEPrescription
THEOPHYLLINE 300MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-06-13Labeling · Supplement 32 · standardAP
2001-10-16Manufacturing (CMC) · Supplement 12AP
2000-10-06Manufacturing (CMC) · Supplement 10AP
2000-07-07Manufacturing (CMC) · Supplement 11AP
1996-10-11Labeling · Supplement 9AP
1995-07-07Manufacturing (CMC) · Supplement 8AP
1994-05-11Manufacturing (CMC) · Supplement 7AP
1993-09-27Manufacturing (CMC) · Supplement 5AP
1992-12-29Manufacturing (CMC) · Supplement 3AP
1992-05-01Labeling · Supplement 4AP
1991-06-24Labeling · Supplement 2AP
1990-08-03Labeling · Supplement 1AP
1990-04-30OriginalAP
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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