APPLICATION
ANDA214806
TYPE
ANDA
ORIGINAL APPROVAL
2023-10-24
LATEST ACTION
2023-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
THEOPHYLLINEPrescription
THEOPHYLLINE 300MG · TABLET, EXTENDED RELEASE · ORAL
THEOPHYLLINEPrescription
THEOPHYLLINE 450MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-10-24UNKNOWN · 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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