APPLICATION
ANDA203046
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-13
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CODEINE SULFATEPrescription
CODEINE SULFATE 60MG · TABLET · ORAL
CODEINE SULFATEPrescription
CODEINE SULFATE 15MG · TABLET · ORAL
CODEINE SULFATEPrescription
CODEINE SULFATE 30MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 21AP
2024-10-31REMS · Supplement 16AP
2018-09-18REMS · Supplement 7AP
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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