APPLICATION
ANDA218401
TYPE
ANDA
ORIGINAL APPROVAL
2025-01-13
LATEST ACTION
2025-03-26
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
THEOPHYLLINEDiscontinued
THEOPHYLLINE 300MG · TABLET, EXTENDED RELEASE · ORAL
THEOPHYLLINEDiscontinued
THEOPHYLLINE 450MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-03-26UNKNOWN · Original · standardAP
2025-01-13UNKNOWN · Original · standardAP
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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