APPLICATION
ANDA081236
TYPE
ANDA
ORIGINAL APPROVAL
1992-11-09
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
THEOPHYLLINEPrescription
THEOPHYLLINE 450MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-06-13Labeling · Supplement 24 · standardAP
2001-10-16Manufacturing (CMC) · Supplement 5AP
2001-05-29Manufacturing (CMC) · Supplement 6AP
2000-10-06Manufacturing (CMC) · Supplement 3AP
2000-07-07Manufacturing (CMC) · Supplement 4AP
1996-10-11Labeling · Supplement 2AP
1994-05-11Manufacturing (CMC) · Supplement 1AP
1992-11-09OriginalAP
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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